Acs®

FDA UDI

Class II (US FDA UDI)

by implantcast GmbH

Identity

Trade Name: ACS® FDA UDI
Generic Name: Orthopaedic reamer guide FDA UDI
Device Name: SC FB tibial reaming guide left FDA UDI
Model / Reference: 42150452 FDA UDI
Description: SC FB tibial reaming guide left FDA UDI

Identifiers

Primary DI / UDI-DI: 04048844211561 FDA UDI
FDA Product Code: JWH FDA UDI
GMDN Term: Orthopaedic reamer guide 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: Orthopaedic reamer guide

Acs® by implantcast GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Arthrex® — Arthrex, Inc. · Class I

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 5d2c19cb-651f-4ddd-b406-5312ee1bb2c5 34 fields · synced Jun 8, 2026