TEMA Elbow

FDA UDI

Class II (US FDA UDI)

by Limacorporate

Identity

Trade Name: TEMA Elbow FDA UDI
Generic Name: Orthopaedic broach FDA UDI
Device Name: Distal Humeral Broach #H8 - LEFT FDA UDI
Model / Reference: 9015.04.080 FDA UDI
Description: Distal Humeral Broach #H8 - LEFT FDA UDI

Identifiers

Catalog Number: 9015.04.080 FDA UDI
Primary DI / UDI-DI: 08033390138246 FDA UDI
FDA Product Code: JDB FDA UDI
JDC FDA UDI
GMDN Term: Orthopaedic broach 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic broach

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Limacorporate

Sources (1)

FDA UDI 3dc9729d-ab24-4302-b87b-40f570e1cdda 35 fields · synced May 31, 2026