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Synicem Hip Spacer Trial Case (marked) Regular

FDA UDI

Class I (US FDA UDI)

by Biocomposites Ltd

Identity

Trade Name
Synicem Hip Spacer Trial Case (marked) Regular FDA UDI
Generic Name
Hip revision prosthesis trial FDA UDI
Device Name
Synicem Hip Spacer Trial Case (marked) Regular FDA UDI
Model / Reference
515091 FDA UDI
Description
Synicem Hip Spacer Trial Case (marked) Regular FDA UDI

Identifiers

Catalog Number
515091 FDA UDI
Primary DI / UDI-DI
15060155712687 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Hip revision prosthesis trial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Hip revision prosthesis trial

Synicem Hip Spacer Trial Case (marked) Regular by Biocomposites Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hip revision prosthesis trial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biocomposites Ltd

Sources (1)

  • FDA UDI 9739a41c-5bba-40ae-b042-77e59abd584e 35 fields · synced Jun 1, 2026