Identity
- Trade Name
- Stephens Instruments FDA UDI
- Generic Name
- Ophthalmic surgical irrigation/infusion/aspiration handle, reusable FDA UDI
- Device Name
- Stephens Bi-Manual Handpiece 23 Ga, Complete Set EUDAMEDBi-Manual Handpiece Set, 23ga FDA UDI
- Model / Reference
- SC-1003 EUDAMEDFDA UDI
- Description
- Bi-Manual Handpiece Set, 23ga FDA UDI
Identifiers
- Catalog Number
- SC-1003 FDA UDI
- Primary DI / UDI-DI
- 00810799038036 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810799038036 EUDAMED
- FDA Product Code
- HMX FDA UDI
- EMDN Code
- L1713 OCULAR IRRIGATION OR SUCTION CANNULAS, REUSABLE EUDAMED
- GMDN Term
- Ophthalmic surgical irrigation/infusion/aspiration handle, 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
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Ophthalmic surgical irrigation/infusion/aspiration handle, 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 Ophthalmic surgical irrigation/infusion/aspiration handle, reusable.
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- Ambler Surgical — Ambler Surgical, LLC · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Bi-Manual Irrigation/Aspiration — AURORA SURGICAL, LLC · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
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 2431ed51-7047-4c6a-864b-7de5d728ddd3 36 fields · synced Jun 19, 2026
- EUDAMED 0edac36e-1540-40e3-8f2e-173229489b8e 61 fields · synced Jun 19, 2026