Identity
- Trade Name
- Stephens Instruments FDA UDI
- Generic Name
- Eyeball fixation instrument, reusable FDA UDI
- Device Name
- Thornton Fixation Ring 12 mm Swinging Handle 1/4 Cut EUDAMEDThornton Fixation Ring, 12mm Swinging handle, Open Ring 1/4 FDA UDI
- Model / Reference
- S1-1211 EUDAMEDFDA UDI
- Description
- Thornton Fixation Ring, 12mm Swinging handle, Open Ring 1/4 FDA UDI
Identifiers
- Catalog Number
- S1-1211 FDA UDI
- Primary DI / UDI-DI
- 00810799031068 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810799031068 EUDAMED
- FDA Product Code
- HNH FDA UDI
- EMDN Code
- L1799 OPHTHALMOLOGY INSTRUMENTS, REUSABLE- OTHER EUDAMED
- GMDN Term
- Eyeball fixation instrument, 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: Eyeball fixation instrument, 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 Eyeball fixation instrument, reusable.
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- Rumex — Rumex International Co. · Class I
- Flieringa Scleral Fixation Ring, 17mm Diameter — AURORA SURGICAL, LLC · Class I
- FINE-THORNTON FIXATION RING 13MM — Katena Products, Inc. · Class I
- Flieringa Scleral Fixation Ring, 24mm — KATALYST SURGICAL, LLC · Class I
- TWIST HOOK RIGHT — Katena Products, 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 362c2f36-a4bb-4685-9345-b7ce9d792f42 36 fields · synced Jul 13, 2026
- EUDAMED 17c7832d-cba3-472d-89a7-272c1c4ece10 61 fields · synced Jul 13, 2026