Identity
- Trade Name
- Stephens Instruments FDA UDI
- Generic Name
- Lens spoon FDA UDI
- Device Name
- Bunge Evisceration Spoon, Medium EUDAMEDFDA UDI
- Model / Reference
- S4-1205 EUDAMEDFDA UDI
- Description
- Bunge Evisceration Spoon, Medium FDA UDI
Identifiers
- Catalog Number
- S4-1205 FDA UDI
- Primary DI / UDI-DI
- 00810799032171 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810799032171 EUDAMED
- FDA Product Code
- HNZ FDA UDI
- EMDN Code
- L1703 OPHTHALMOLOGY CURETTES, REUSABLE EUDAMED
- GMDN Term
- Lens spoon 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 spoon
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 spoon.
- Ophthalmic Spoon — Katena Products, Inc. · Class I
- Opthalmic Spoon — OVATION INTERNATIONAL · Class I
- V. Mueller — STERIS CORPORATION · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- Sklar — Sklar Corporation · Class I
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- Opthalmic Spoon — OVATION INTERNATIONAL · Class I
- Opthalmic Spoon — OVATION INTERNATIONAL · 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 af31b3ac-ec2e-4066-8310-ae21fc8cb86f 36 fields · synced Jun 18, 2026
- EUDAMED 7d5f9517-2e7f-410e-9a77-b5887e8cba0c 61 fields · synced Jun 18, 2026