← Back to catalogue

TEMA Elbow

FDA UDI

Class I (US FDA UDI)

by Limacorporate

Identity

Trade Name
TEMA Elbow FDA UDI
Generic Name
Humeral stem extension prosthesis trial FDA UDI
Device Name
Trial Humeral Body Large - RIGHT FDA UDI
Model / Reference
9015.50.221 FDA UDI
Description
Trial Humeral Body Large - RIGHT FDA UDI

Identifiers

Catalog Number
9015.50.221 FDA UDI
Primary DI / UDI-DI
08033390190626 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Humeral stem extension 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

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: Humeral stem extension prosthesis trial

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

Similar devices

Also classified as Humeral stem extension prosthesis trial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Limacorporate

Sources (1)

  • FDA UDI 6266f6ca-afc7-4140-8be3-b22cfe577d40 35 fields · synced May 30, 2026