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, reusable FDA UDI
Device Name: Radial Marker, 8 Incisions, 90 Degree FDA UDI
Model / Reference: S9-1115 FDA UDI
Description: Radial Marker, 8 Incisions, 90 Degree FDA UDI

Identifiers

Catalog Number: S9-1115 FDA UDI
Primary DI / UDI-DI: 00810799037640 FDA UDI
FDA Product Code: HMQ FDA UDI
GMDN Term: Ophthalmic angular gauge, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Ophthalmic angular gauge, reusable

Stephens Instruments by Krishna Imports Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 f4a43161-413a-4446-abbb-e33890d42e45 36 fields · synced Jun 8, 2026