Identity
- Trade Name
- Stephens Instruments FDA UDI
- Generic Name
- Corneal bur handpiece, battery-powered FDA UDI
- Device Name
- Pterygium Brush, 3.5 mm Med. Grit EUDAMEDPterygium Brush. 3.5mm Round Tip, Medium Grit, Diamond Dusted FDA UDI
- Model / Reference
- S2-1177 EUDAMEDFDA UDI
- Description
- Pterygium Brush. 3.5mm Round Tip, Medium Grit, Diamond Dusted FDA UDI
Identifiers
- Catalog Number
- S2-1177 FDA UDI
- Primary DI / UDI-DI
- 00810799031464 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810799031464 EUDAMED
- FDA Product Code
- HOF FDA UDI
- EMDN Code
- L1799 OPHTHALMOLOGY INSTRUMENTS, REUSABLE- OTHER EUDAMED
- GMDN Term
- Corneal bur handpiece, battery-powered 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: Corneal bur handpiece, battery-powered
Stephens Instruments by Krishna Imports Inc — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Krishna Imports Inc
Sources (2)
- FDA UDI ab1ff975-a369-4e56-aeca-5d8f4404ff2e 36 fields · synced Jul 9, 2026
- EUDAMED 72f4cfca-2886-45e9-8a8a-dccbf65b8593 61 fields · synced Jul 9, 2026