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TEMA Elbow

FDA UDI

Class II (US FDA UDI)

by Limacorporate

Identity

Trade Name
TEMA Elbow FDA UDI
Generic Name
Orthopaedic implant impactor, reusable FDA UDI
Device Name
Ulnar Implant Impactor FDA UDI
Model / Reference
9015.52.140 FDA UDI
Description
Ulnar Implant Impactor FDA UDI

Identifiers

Catalog Number
9015.52.140 FDA UDI
Primary DI / UDI-DI
08033390139199 FDA UDI
FDA Product Code
JDB FDA UDI
JDC FDA UDI
GMDN Term
Orthopaedic implant impactor, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3160 FDA UDI
888.3150 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: Orthopaedic implant impactor, reusable

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

Similar devices

Also classified as Orthopaedic implant impactor, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Limacorporate

Sources (1)

  • FDA UDI 88dc0e09-b8c9-4a60-b54a-ac2f11577ca7 34 fields · synced May 30, 2026