Sklar®

FDA UDI

Class II (US FDA UDI)

by Sklar Corporation

Identity

Trade Name: Sklar® FDA UDI
Generic Name: Obstetrical forceps, reusable FDA UDI
Model / Reference: 92-1112 FDA UDI

Identifiers

Primary DI / UDI-DI: 10649111211942 FDA UDI
510(k) Number: K092827 FDA UDI
FDA Product Code: HDA FDA UDI
GMDN Term: Obstetrical forceps, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.4400 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Obstetrical forceps, reusable

Sklar® by Sklar Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Obstetrical forceps, reusable.

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Avalign — AVALIGN TECHNOLOGIES, Inc. · Class II
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I

Cleared under the same submission

K092827 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Sklar Corporation

Sources (1)

FDA UDI ce4e9fe7-e038-445d-8ac6-9fb0cea6c2ef 33 fields · synced May 30, 2026