Amnio‑Patch™ — Allograft Tissue Information & Product Preparation Insert

(Formatted from IFU content)

📦 Contents / How Supplied

This package contains Human Cellular and Tissue‑Based Products (HCT/P) as defined under US FDA 21 CFR Part 1271 .

CAUTION: Federal (USA) law restricts this product to sale by, or on the order of, a licensed physician.

The donated human tissue has been determined eligible for transplantation by a licensed Medical Director according to the criteria listed in the Donor Selection section.

🧬 Product Description

Amnio‑Patch™ is a dehydrated amniotic allograft membrane provided in multiple geometric configurations. The membrane:

• Is dehydrated during processing and should appear visibly dry when opened

• Is packaged in a sterile inner peel pouch

• Is terminally sterilized via E‑beam irradiation

• May be placed directly into the sterile field

• Includes a Tracing Record and patient labels for HCT/P tracking

Single‑use only:

• Sterile, single‑patient, one‑time use

• Once opened, must be used immediately or discarded

🏢 Introduction

Akriti Ophthalmic Pvt Ltd is FDA‑registered as a manufacturer of HCT/Ps, and Smart Technology LLC is the distributor in the United States .

🩺 Donor Selection & Eligibility

The Medical Director has determined donor eligibility based on:

1. Donor Screening

Donor was free from risk factors and clinical evidence of infection due to relevant communicable diseases.

2. Donor Testing

All tests performed by FDA‑registered, CLIA‑certified laboratories. Testing includes:

• Anti‑HIV‑1 & Anti‑HIV‑2

• HIV‑1 / HBV / HCV by Transcription Mediated Amplification

• Hepatitis B surface antigen (HBsAg)

• Hepatitis B total core antibody

• Anti‑HCV

• Anti‑HTLV‑I & Anti‑HTLV‑II

• Syphilis (FDA‑licensed tests)

• West Nile Virus (WNV NAT test)

3. Donor Medical Review

• Medical history

• Behavior risk assessment

• Physical assessment

• Culture results at recovery

• Physician/maternal interviews

• Comprehensive review by licensed Medical Director

All donor records, test interpretations, and laboratory details can be retrieved upon request.

🧼 Recovery

Tissue recovery is performed aseptically, with medical records collected and reviewed at the time of recovery.

🏭 Processing

Amnio‑Patch™ is processed in a controlled clean‑environment facility using validated methods to prevent contamination and cross‑contamination. Technical quality assurance standards are rigorously maintained.

🚚 Tissue Distribution

Distributed by Smart Technology LLC, Cleveland, Ohio, USA.

📦 Tissue Storage

Maintain Amnio‑Patch™ in original packaging at room temperature until ready for use.

🔗 HCT/P Tracking Requirements

Recipient records must be maintained for post‑transplant tissue tracing per:

• The Joint Commission

• FDA requirements

Allograft ID must be recorded in the operative record. Tracing Record card must be completed and returned. Patient labels are provided for tracking.

🩹 General Usage

Amnio‑Patch™ is intended for use as a wound cover and protective barrier during soft‑tissue repair under physician direction.

⚠️ Precautions

1. Do not use in presence of active infection.

2. Donor screening may not detect all diseases.

3. Possible complications include:

   • Transmission of communicable diseases

   • Transmission of infectious agents (viruses, bacteria, fungi)

   • Immune rejection or allergic reaction to implanted HCT/P

🚨 Adverse Reactions

Defined by FDA as any noxious or unintended response possibly caused by the HCT/P. Report immediately to Akriti Ophthalmic Pvt Ltd Customer Service: +1‑216‑239‑9880

🔧 Recommended Instructions for Use

(General guidelines; not a substitute for clinical judgment)

Preparation

1. Open carton and remove foil pouch.

2. Peel outer foil pouch; remove sterile inner aluminum pouch.

   • Inner pouch may be placed directly into sterile field.

3. Remove graft from pouch and position at desired anatomical site.

4. Secure using physician’s preferred fixation method.

Handling Notes

• Graft is lightweight; handle carefully.

• Translucent off‑white/yellowish appearance is normal.

• A dry recipient surface improves adherence.

↩️ Return Policy

• Requires Return Authorization (RA) number

• Product must be unopened and in resalable condition

• Contact Smart Technology LLC Customer Service

Note: Akriti makes no claims regarding biological properties of allograft tissue. All tissue is processed per FDA HCT/P regulations, but disease transmission cannot be fully eliminated.

📜 Product Information Disclosure

Smart Technology LLC exercises reasonable care in manufacturing but excludes all warranties, including implied warranties of merchantability or fitness for a particular purpose. Not liable for incidental or consequential damages. No additional liability is authorized beyond stated terms.

Please read before purchase. The information provided regarding dietary supplements or ointments are not to be taken as medical advice.

Consult a healthcare professional prior to use if you are pregnant, nursing, taking medication, or have a medical condition.

Keep out of reach of children. Store in a cool, dry place. Do not use if seal under cap is broken or missing.

Order by 2PM to get delivered next working day! We use 24 hours service with carriers in most cases so that you can get your order delivered on time.

There is €4.99 charge for delivery under €50 Orders. Additional charges will be imposed by our couriers for delivery to remote area, a surcharge may be levied to cover carriage to these areas.

Please note: Exposure to heat or sunlight may lead to melting/damage of product. Hence customers are expected to be available during the product delivery.