Identity
- Trade Name
- Stephens Instruments FDA UDI
- Generic Name
- Lens loop, reusable FDA UDI
- Device Name
- Simcoe Double Lens Loop EUDAMEDFDA UDI
- Model / Reference
- S4-1191 EUDAMEDFDA UDI
- Description
- Simcoe Double Lens Loop FDA UDI
Identifiers
- Catalog Number
- S4-1191 FDA UDI
- Primary DI / UDI-DI
- 00810799032157 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810799032157 EUDAMED
- FDA Product Code
- HNQ FDA UDI
- EMDN Code
- L1711 OPHTHALMOLOGY HOOKS, REUSABLE EUDAMED
- GMDN Term
- Lens loop, 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: Lens loop, 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 Lens loop, reusable.
- Walcott Rx Products — Walcott Rx Product Inc · Class I
- BECHERT LENS NUCLEUS ROTATOR — SONTEC INSTRUMENTS, INC. · Class I
- gSource — GSOURCE, LLC. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- Bausch + Lomb — Bausch & Lomb Incorporated · Class I
- Bausch + Lomb — Bausch & Lomb Incorporated · 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 d7d29bf7-c4a8-4ae2-97f7-bcc825d05d30 36 fields · synced Jun 14, 2026
- EUDAMED 6ff4f2be-09a5-48a0-9e8a-1aae54435f94 61 fields · synced Jun 11, 2026