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TEMA Elbow

FDA UDI

Class II (US FDA UDI)

by Limacorporate

Identity

Trade Name
TEMA Elbow FDA UDI
Generic Name
Surgical instrument handle, torque-limiting FDA UDI
Device Name
Counter Torque for Humeral Safety Screw FDA UDI
Model / Reference
9015.50.900 FDA UDI
Description
Counter Torque for Humeral Safety Screw FDA UDI

Identifiers

Catalog Number
9015.50.900 FDA UDI
Primary DI / UDI-DI
08033390138529 FDA UDI
FDA Product Code
JDC FDA UDI
JDB FDA UDI
GMDN Term
Surgical instrument handle, torque-limiting 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: Surgical instrument handle, torque-limiting

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

Similar devices

Also classified as Surgical instrument handle, torque-limiting.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Limacorporate

Sources (1)

  • FDA UDI e99ca91a-acfa-430c-a0c4-39804d38f59a 34 fields · synced May 31, 2026