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OsteoBridge™

FDA UDI

Class I (US FDA UDI)

by Merete GmbH

Identity

Trade Name
OsteoBridge™ FDA UDI
Generic Name
Knee arthrodesis prosthesis FDA UDI
Device Name
OsteoBridge IKA Knee Arthrodesis Trial Nail with Collar DIA 12/30 Length 130 mm non-sterile FDA UDI
Model / Reference
GA31213 FDA UDI
Description
OsteoBridge IKA Knee Arthrodesis Trial Nail with Collar DIA 12/30 Length 130 mm non-sterile FDA UDI

Identifiers

Primary DI / UDI-DI
04048266079046 FDA UDI
FDA Product Code
HWT FDA UDI
GMDN Term
Knee arthrodesis prosthesis FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Knee arthrodesis prosthesis

OsteoBridge™ by Merete GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Knee arthrodesis prosthesis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Merete GmbH

Sources (1)

  • FDA UDI 2e41568b-2e11-48ff-99ad-cc1b825d1671 34 fields · synced May 31, 2026