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OsteoBridge™ IDSF Diaphysis Tibial Nail

FDA UDI

Class I (US FDA UDI)

by Merete GmbH

Identity

Trade Name
OsteoBridge™ IDSF Diaphysis Tibial Nail FDA UDI
Generic Name
Diaphysis prosthesis FDA UDI
Model / Reference
10 90 FDA UDI

Identifiers

Catalog Number
GB41009S FDA UDI
Primary DI / UDI-DI
04048266166678 FDA UDI
510(k) Number
K181026 FDA UDI
FDA Product Code
HBS FDA UDI
GMDN Term
Diaphysis prosthesis FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
882.4190 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

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 10 Millimeter FDA UDI
Length — 90 Millimeter FDA UDI

Category: Diaphysis prosthesis

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

Similar devices

Also classified as Diaphysis prosthesis.

Cleared under the same submission

K181026 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Merete GmbH

Sources (1)

  • FDA UDI 2165dad9-00d1-43fc-bf2a-597849cad846 36 fields · synced Jun 1, 2026