Identity
- Trade Name
- Stephens Instruments FDA UDI
- Generic Name
- Corneoscleral punch FDA UDI
- Device Name
- Gass Punch EUDAMEDFDA UDI
- Model / Reference
- S3-1038 EUDAMEDFDA UDI
- Description
- Gass Punch FDA UDI
Identifiers
- Catalog Number
- S3-1038 FDA UDI
- Primary DI / UDI-DI
- 00810799031570 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810799031570 EUDAMED
- FDA Product Code
- HNJ FDA UDI
- EMDN Code
- L170401 CORNEAL TREPHINES, REUSABLE EUDAMED
- GMDN Term
- Corneoscleral punch FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- Norway EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Corneoscleral punch
Stephens Instruments by Krishna Imports Inc — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Corneoscleral punch.
- MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
- Corneal Trephine Blade Ø 8.5 mm Stainless Steel — SURTEX INSTRUMENTS LTD · Class I
- Punches — AURORA SURGICAL, LLC · Class I
- ASELTECH — Asel Tibbi Aletler A.S. · Class I
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- ATLAS — ATLAS CERRAHİ ALETLER LTD. ŞTİ. · Class I
- V. Mueller — STERIS CORPORATION · Class I
- Corneal Trephine Handle Ø 7.5 mm Stainless Steel — SURTEX INSTRUMENTS LTD · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| 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
- Krishna Imports Inc
Sources (2)
- FDA UDI 10f81f62-e1dc-4f7b-a2e7-50e72c0a6c00 36 fields · synced Jun 19, 2026
- EUDAMED abd1d007-b026-4fa4-bb26-7821b1582007 61 fields · synced Jun 19, 2026