Acs®

FDA UDI

Class II (US FDA UDI)

by implantcast GmbH

Identity

Trade Name: ACS® FDA UDI
Generic Name: Bone-resection orthopaedic reamer, reusable FDA UDI
Device Name: FB tibial reamer FDA UDI
Model / Reference: 42150003 FDA UDI
Description: FB tibial reamer FDA UDI

Identifiers

Primary DI / UDI-DI: 04048844118051 FDA UDI
FDA Product Code: JWH FDA UDI
GMDN Term: Bone-resection orthopaedic reamer, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone-resection orthopaedic reamer, reusable

Acs® by implantcast GmbH — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: implantcast GmbH

Sources (1)

FDA UDI 19bb1f59-202c-4e13-bd7c-724be040ec9d 33 fields · synced Jun 8, 2026