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Stephens Instruments

FDA UDI

Class I (US FDA UDI)

by Krishna Imports Inc

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
Sterilization Method
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

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Manufacturer

Manufacturer
Krishna Imports Inc

Sources (1)

  • FDA UDI 6335e067-3a22-4105-9dac-8b00474c67e1 36 fields · synced May 30, 2026