Wire Speculum

FDA UDI

Class I (US FDA UDI)

by Sontec Instruments, Inc.

Identity

Trade Name: Wire Speculum FDA UDI
Generic Name: Eyelid speculum, reusable FDA UDI
Device Name: Wire Speculum With Left 3rd Eyelid Blade Closed Blades Titanium FDA UDI
Model / Reference: T10-1013 FDA UDI
Description: Wire Speculum With Left 3rd Eyelid Blade Closed Blades Titanium FDA UDI

Identifiers

Catalog Number: T10-1013 FDA UDI
Primary DI / UDI-DI: 00192896116849 FDA UDI
FDA Product Code: HNC FDA UDI
GMDN Term: Eyelid speculum, reusable 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Dry Heat Sterilization FDA UDI

Category: Eyelid speculum, reusable

Wire Speculum by Sontec Instruments, 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: Sontec Instruments, Inc.

Sources (1)

FDA UDI f41bcf82-3b45-4649-ade6-fcada4c4d368 36 fields · synced May 30, 2026