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TEMA Elbow

FDA UDI

Class II (US FDA UDI)

by Limacorporate

Identity

Trade Name
TEMA Elbow FDA UDI
Generic Name
Metal-backed elbow ulna prosthesis FDA UDI
Device Name
Ulnar Stem U6 FDA UDI
Model / Reference
1575.14.030 FDA UDI
Description
Ulnar Stem U6 FDA UDI

Identifiers

Catalog Number
1575.14.030 FDA UDI
Primary DI / UDI-DI
08033390140317 FDA UDI
FDA Product Code
JDC FDA UDI
JDB FDA UDI
GMDN Term
Metal-backed elbow ulna prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3150 FDA UDI
888.3160 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

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Metal-backed elbow ulna prosthesis

TEMA Elbow by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metal-backed elbow ulna prosthesis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Limacorporate

Sources (1)

  • FDA UDI 9ff3e2a2-f059-472b-9d4f-85631c24d186 35 fields · synced Jun 6, 2026