Comfort Plus Mallet

FDA UDI

Class I (US FDA UDI)

by Koros USA, Inc.

Identity

Trade Name: Comfort Plus Mallet FDA UDI
Generic Name: Surgical mallet FDA UDI
Device Name: Comfort Plus Small Bone Mallet 12cm, 18oz FDA UDI
Model / Reference: 7530-12 FDA UDI
Description: Comfort Plus Small Bone Mallet 12cm, 18oz FDA UDI

Identifiers

Catalog Number: 7530-12 FDA UDI
Primary DI / UDI-DI: 10840199528582 FDA UDI
FDA Product Code: GFJ FDA UDI
GMDN Term: Surgical mallet 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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 mallet

Comfort Plus Mallet by Koros USA, Inc. — 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: Koros USA, Inc.

Sources (1)

FDA UDI ee5cff7b-1128-484f-892c-a34e00350c78 37 fields · synced May 30, 2026