Amnio‑Disc™ 6.00mm

Amnio‑Disc™ 

Contents / How Supplied Human Cellular and Tissue-Based Product (HCT/P) per FDA 21 CFR 1271. Federal law restricts sale to licensed physicians. Donor tissue deemed eligible by Medical Director.

Product Description Circular dehydrated amniotic membrane allograft for ophthalmic and wound‑care use. Available diameters: 6, 8, 10, 12, 14, 16 mm. Dehydrated; appears dry when opened. Terminally sterilized via E‑beam. Sterile, single‑patient, one‑time use. Includes Tracing Record and patient labels. Use immediately after opening.

Introduction Manufactured by Akriti Ophthalmic Pvt Ltd (FDA‑registered). Distributed by Smart Technology LLC.

Donor Selection Donor screened and found free of risk factors and clinical evidence of infection. Testing negative/nonreactive for: HIV‑1/2, HIV/HBV/HCV (TMA), HBsAg, HBcAb, anti‑HCV, HTLV‑I/II, Syphilis (FDA‑licensed), West Nile Virus (NAT). Testing performed by FDA‑registered, CLIA‑certified labs. Medical history, behavior risk assessment, physical exam, culture results reviewed by licensed Medical Director.

Recovery Tissue recovered aseptically; medical records reviewed.

Processing Processed in controlled, validated clean‑environment facility. Methods prevent contamination and cross‑contamination. Quality assurance maintained.

Tissue Distribution Distributed by Smart Technology LLC.

Tissue Storage Store in original packaging at room temperature.

HCT/P Tracking Record allograft ID in operative record. Complete and return Tracing Record card. Patient labels included.

General Usage Intended as wound cover and protective barrier for soft‑tissue repair. Ophthalmic uses: ocular surface protection, conjunctival defects, pterygium surgery, small corneal epithelial defects, minor scleral reinforcement.

Precautions Do not use in presence of active infection. Donor screening may not detect all diseases. Possible complications: disease transmission, infectious agents, immune rejection, allergic reaction.

Adverse Reactions Report adverse reactions to Akriti Ophthalmic Pvt Ltd Customer Service: 1‑216‑239‑9880.

Instructions for Use

1. Open carton; remove foil pouch.

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

3. Open inner pouch; place implant in sterile field.

4. Handle carefully; graft is lightweight and translucent.

5. Apply to dry recipient surface.

6. Position graft at desired anatomical site.

7. Secure using preferred fixation method.

Return Policy Return Authorization (RA) required. Product must be unopened and resalable.

Product Information Disclosure Smart Technology excludes all warranties, including merchantability or fitness for purpose. Not liable for incidental or consequential damages.