Sklar®

FDA UDI

Class I (US FDA UDI)

by Sklar Corporation

Identity

Trade Name: Sklar® FDA UDI
Generic Name: Surgical gouge FDA UDI
Device Name: COBB OSTEOTOME STR 11" 13MM FDA UDI
Model / Reference: 40-7492 FDA UDI
Description: COBB OSTEOTOME STR 11" 13MM FDA UDI

Identifiers

Primary DI / UDI-DI: 10649111210754 FDA UDI
FDA Product Code: EMM FDA UDI
GMDN Term: Surgical gouge FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical gouge

Sklar® by Sklar Corporation — 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: Sklar Corporation

Sources (1)

FDA UDI 12f87ecb-4d91-4e6b-a918-3d6842783498 33 fields · synced Jun 1, 2026