Identity
- Trade Name
- Stephens Instruments FDA UDI
- Generic Name
- Ophthalmic angular gauge, single-use FDA UDI
- Device Name
- Braunstein Fixed Caliper, Incision Gauge, 3.5mm/4.0mm, Single Use, 10/Box FDA UDI
- Model / Reference
- SSD4 1457 FDA UDI
- Description
- Braunstein Fixed Caliper, Incision Gauge, 3.5mm/4.0mm, Single Use, 10/Box FDA UDI
Identifiers
- Catalog Number
- SSD4 1457 FDA UDI
- Primary DI / UDI-DI
- 00810799039514 FDA UDI
- FDA Product Code
- HOE FDA UDI
- GMDN Term
- Ophthalmic angular gauge, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Ophthalmic angular gauge, single-use
Stephens Instruments by Krishna Imports Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic angular gauge, single-use.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Krishna Imports Inc
Sources (1)
- FDA UDI 6335e067-3a22-4105-9dac-8b00474c67e1 36 fields · synced May 30, 2026