Identity
- Trade Name
- Stephens Instruments FDA UDI
- Generic Name
- Corneal bur, abrasion FDA UDI
- Device Name
- Pterygium Tip/Burr 2.5 mm Round Tip, Fine Grit EUDAMEDChuck and Burr, For Pterygium Brush, 2.5mm Round Tip, Fine Grit, Diamond Dusted FDA UDI
- Model / Reference
- S2-1178 EUDAMEDFDA UDI
- Description
- Chuck and Burr, For Pterygium Brush, 2.5mm Round Tip, Fine Grit, Diamond Dusted FDA UDI
Identifiers
- Catalog Number
- S2-1178 FDA UDI
- Primary DI / UDI-DI
- 00810799031471 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810799031471 EUDAMED
- FDA Product Code
- HOF FDA UDI
- EMDN Code
- L1799 OPHTHALMOLOGY INSTRUMENTS, REUSABLE- OTHER EUDAMED
- GMDN Term
- Corneal bur, abrasion 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, abrasion
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 Corneal bur, abrasion.
- Stephens Instruments — KRISHNA IMPORTS INC · 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 |
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Manufacturer
- Manufacturer
- Krishna Imports Inc
Sources (2)
- FDA UDI 43ec3160-c2f1-485c-9284-c8cabb9a657b 36 fields · synced Jul 10, 2026
- EUDAMED bcc7e94b-8fd3-40c0-8582-bd34ccb01e97 61 fields · synced Jul 10, 2026