Dornhoffer Nytebyte Partial W/Windows

FDA UDI

Class II (US FDA UDI)

by Grace Medical, Inc.

Identity

Trade Name: DORNHOFFER NYTEBYTE PARTIAL W/WINDOWS FDA UDI
Generic Name: Ossicular prosthesis, partial FDA UDI
Device Name: DORNHOFFER NYTEBYTE PARTIAL W/WINDOWS 1.00MM FIXED LENGTH HA/TITANIUM/NITINOL FDA UDI
Model / Reference: 692-100 FDA UDI
Description: DORNHOFFER NYTEBYTE PARTIAL W/WINDOWS 1.00MM FIXED LENGTH HA/TITANIUM/NITINOL FDA UDI

Identifiers

Primary DI / UDI-DI: 00844505013109 FDA UDI
FDA Product Code: ETB FDA UDI
GMDN Term: Ossicular prosthesis, partial FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.3450 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

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: Ossicular prosthesis, partial

Dornhoffer Nytebyte Partial W/Windows by Grace Medical, Inc. — 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: Grace Medical, Inc.

Sources (1)

FDA UDI c35417f2-1e1b-4648-b957-bf20d585debf 34 fields · synced May 30, 2026