Wedge Incus Strut Long

FDA UDI

Class II (US FDA UDI)

by Grace Medical, Inc.

Identity

Trade Name: WEDGE INCUS STRUT LONG FDA UDI
Generic Name: Ossicular prosthesis, partial FDA UDI
Device Name: WEDGE INCUS STRUT LONG SIZERS INCLUDED TITANIUM/SILICONE FDA UDI
Model / Reference: 656 FDA UDI
Description: WEDGE INCUS STRUT LONG SIZERS INCLUDED TITANIUM/SILICONE FDA UDI

Identifiers

Primary DI / UDI-DI: 00844505012911 FDA UDI
FDA Product Code: ETB FDA UDI
JYJ FDA UDI
GMDN Term: Ossicular prosthesis, partial FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.3450 FDA UDI
874.4420 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Surgical implant template, single-use Ossicular prosthesis, partial

Wedge Incus Strut Long by Grace Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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MatriX Stapes Prosthesis Titanium — Heinz Kurz · Class II
Gyrus ACMI — Gyrus Acmi, Inc. · Class II
Gyrus ACMI — Gyrus Acmi, Inc. · Class II
Soft CliP Titanium — Heinz Kurz · Class II

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: Grace Medical, Inc.

Sources (1)

FDA UDI c54bb3cd-2b00-4739-be51-bdd8b0fbdb61 34 fields · synced May 30, 2026