Identity
- Trade Name
- Stephens Instruments FDA UDI
- Generic Name
- Orbital depressor, reusable FDA UDI
- Device Name
- Josephberg-Besser Scleral Depressor EUDAMEDJosephberg-Besser Scleral Depressor, Double Ended FDA UDI
- Model / Reference
- S4-1236 EUDAMEDFDA UDI
- Description
- Josephberg-Besser Scleral Depressor, Double Ended FDA UDI
Identifiers
- Catalog Number
- S4-1236 FDA UDI
- Primary DI / UDI-DI
- 00810799032232 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810799032232 EUDAMED
- FDA Product Code
- HNX FDA UDI
- EMDN Code
- L1799 OPHTHALMOLOGY INSTRUMENTS, REUSABLE- OTHER EUDAMED
- GMDN Term
- Orbital depressor, reusable 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: Orbital depressor, reusable
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 Orbital depressor, reusable.
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
- V. Mueller — STERIS CORPORATION · Class I
- Bausch + Lomb — Bausch & Lomb Incorporated · Class I
- Schepens Scleral Depressor — SONTEC INSTRUMENTS, INC. · Class I
- Ambler Surgical — Ambler Surgical, LLC · 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 04e4a12a-3739-4d47-b3b2-b71751faca40 36 fields · synced Jul 14, 2026
- EUDAMED e635baf3-fdc5-4bad-a79f-1e558a158b16 61 fields · synced Jul 14, 2026