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Sklar®

FDA UDI

Class I (US FDA UDI)

by Sklar Corporation

Identity

Trade Name
Sklar® FDA UDI
Generic Name
Skin/tissue hook FDA UDI
Device Name
JOSEPH HOOK 2PRG SH 5MM BX12 FDA UDI
Model / Reference
21-394 FDA UDI
Description
JOSEPH HOOK 2PRG SH 5MM BX12 FDA UDI

Identifiers

Primary DI / UDI-DI
40649111049195 FDA UDI
FDA Product Code
GDG FDA UDI
GMDN Term
Skin/tissue hook FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Skin/tissue hook

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

Similar devices

Also classified as Skin/tissue hook.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sklar Corporation

Sources (1)

  • FDA UDI b6d3dcc3-9139-4ad6-b1b3-8861f8ec81ac 33 fields · synced May 30, 2026