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Comfort Plus Chisel Set

FDA UDI

Class I (US FDA UDI)

by Koros USA, Inc.

Identity

Trade Name
Comfort Plus Chisel Set FDA UDI
Generic Name
Orthopaedic chisel FDA UDI
Device Name
Comfort Plus Chisel Curved 16.5cm Set Consists of the Following: 1 x 7542-05, 1 x 7542-10, 1 x 7542-15, 1 x 7542-20, 1 x 7542-25 & 1 x 7542-30 FDA UDI
Model / Reference
7542-00 FDA UDI
Description
Comfort Plus Chisel Curved 16.5cm Set Consists of the Following: 1 x 7542-05, 1 x 7542-10, 1 x 7542-15, 1 x 7542-20, 1 x 7542-25 & 1 x 7542-30 FDA UDI

Identifiers

Catalog Number
7542-00 FDA UDI
Primary DI / UDI-DI
10840199544032 FDA UDI
FDA Product Code
KDG FDA UDI
GMDN Term
Orthopaedic chisel FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4820 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

Yes

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: Orthopaedic chisel

Comfort Plus Chisel Set by Koros USA, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic chisel.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Koros USA, Inc.

Sources (1)

  • FDA UDI cc8c51cb-8216-4102-9d2e-b1ff83ce246b 37 fields · synced May 30, 2026