Identity
- Trade Name
- IRIS SCISSORS FDA UDI
- Generic Name
- Intraocular scissors, conventional-hinge, reusable FDA UDI
- Device Name
- IRIS SCISSORS SHARP CURVED BLADE POWER CUT GOLD FDA UDI
- Model / Reference
- 1200-012 FDA UDI
- Description
- IRIS SCISSORS SHARP CURVED BLADE POWER CUT GOLD FDA UDI
Identifiers
- Catalog Number
- 1200-012 FDA UDI
- Primary DI / UDI-DI
- 00192896054233 FDA UDI
- FDA Product Code
- HNF FDA UDI
- GMDN Term
- Intraocular scissors, conventional-hinge, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 4.5 Inch FDA UDI
Category: Intraocular scissors, conventional-hinge, reusable
Iris Scissors by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intraocular scissors, conventional-hinge, reusable.
- Sklar® — Sklar Corporation · Class I
- SCISSORS — KLS-Martin L.P. · Class I
- Bausch + Lomb — Bausch & Lomb Incorporated · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- Iris Scissors — AURORA SURGICAL, LLC · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI 2878e203-97fc-4e44-b2b8-7d4cfe957b58 36 fields · synced May 31, 2026