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TEMA Elbow

FDA UDI

Class II (US FDA UDI)

by Limacorporate

Identity

Trade Name
TEMA Elbow FDA UDI
Generic Name
Elbow ulna prosthesis trial FDA UDI
Device Name
Trial Ulnar Stem #U7 FDA UDI
Model / Reference
9015.75.150 FDA UDI
Description
Trial Ulnar Stem #U7 FDA UDI

Identifiers

Catalog Number
9015.75.150 FDA UDI
Primary DI / UDI-DI
08033390138963 FDA UDI
FDA Product Code
JDC FDA UDI
JDB FDA UDI
GMDN Term
Elbow ulna prosthesis trial 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

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

No

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: Elbow ulna prosthesis trial

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

Similar devices

Also classified as Elbow ulna prosthesis trial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Limacorporate

Sources (1)

  • FDA UDI 4e036f58-4527-43fb-b397-f7a4b9014cf1 35 fields · synced May 30, 2026