Identity
- Trade Name
- Stephens Instruments FDA UDI
- Generic Name
- Trabeculotomy probe FDA UDI
- Device Name
- Harms Trabeculotomy Probe-Left EUDAMEDHarms Trabeculotomy Probe, Left FDA UDI
- Model / Reference
- S8-1005 EUDAMEDFDA UDI
- Description
- Harms Trabeculotomy Probe, Left FDA UDI
Identifiers
- Catalog Number
- S8-1005 FDA UDI
- Primary DI / UDI-DI
- 00810799037152 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810799037152 EUDAMED
- FDA Product Code
- HNK FDA UDI
- EMDN Code
- L1705 OPHTHALMOLOGY PROBES, REUSABLE EUDAMED
- GMDN Term
- Trabeculotomy probe 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: Trabeculotomy probe
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 Trabeculotomy probe.
- Sklar® — Sklar Corporation · Class I
- Sklar® — Sklar Corporation · Class I
- Stephens Instruments — KRISHNA IMPORTS 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 97d9a744-1b7d-44fc-b793-3b3b057b1d1b 36 fields · synced Jun 18, 2026
- EUDAMED 65b17ae3-a0b9-4f8d-82ca-608a8b6ed22d 61 fields · synced Jun 18, 2026