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Sklar®

FDA UDI

Class I (US FDA UDI)

by Sklar Corporation

Identity

Trade Name
Sklar® FDA UDI
Generic Name
Mastoid chisel FDA UDI
Device Name
ALEXANDER CHISEL 7" 14MM FDA UDI
Model / Reference
67-4614 FDA UDI
Description
ALEXANDER CHISEL 7" 14MM FDA UDI

Identifiers

Primary DI / UDI-DI
10649111068317 FDA UDI
FDA Product Code
FZO FDA UDI
GMDN Term
Mastoid chisel 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

No

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Mastoid chisel

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

Similar devices

Also classified as Mastoid chisel.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sklar Corporation

Sources (1)

  • FDA UDI 4856daa9-e1ef-4d92-b285-999bc903d586 33 fields · synced Jun 8, 2026