Identity
- Trade Name
- SCISSORS FDA UDI
- Generic Name
- Ophthalmic surgical instrument handle, pneumatic FDA UDI
- Device Name
- IRIS SCISSORS CVD 4-1/2" POLISH LARGE LOOP FDA UDI
- Model / Reference
- IRIS SCISSORS FDA UDI
- Description
- IRIS SCISSORS CVD 4-1/2" POLISH LARGE LOOP FDA UDI
Identifiers
- Catalog Number
- IC164L FDA UDI
- Primary DI / UDI-DI
- B974IC164L05 FDA UDI
- FDA Product Code
- LRW FDA UDI
- GMDN Term
- Ophthalmic surgical instrument handle, pneumatic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Length — 4.5 Inch FDA UDI
Category: Ophthalmic surgical instrument handle, pneumatic
Scissors by Dr.frigz International(pvt)ltd, — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic surgical instrument handle, pneumatic.
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- 25G Two Dimensional Cutter – 20k CPM — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- Disposable High Speed TDC Cutter 25 G / 8000 CPM DORC Continuum range — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- 27G Two Dimensional Cutter – 20k CPM — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- 25G Two Dimensional Cutter – 16k CPM — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- Disposable High Speed TDC Cutter 25 G / 8000 CPM DORC Continuum range — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- MICROTEK — Microtek Medical LLC · Class II
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 |
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Manufacturer
- Manufacturer
- Dr.frigz International(pvt)ltd,
Sources (1)
- FDA UDI 38fc245a-351c-4d4e-a616-72eab7116b1f 35 fields · synced May 29, 2026