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Tempfix®rod Assembly

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name
TEMPFIX®ROD ASSEMBLY FDA UDI
Generic Name
External orthopaedic fixation system, single-use FDA UDI
Model / Reference
8181-15-000 FDA UDI

Identifiers

Catalog Number
818115000 FDA UDI
Primary DI / UDI-DI
00887868047763 FDA UDI
FDA Product Code
HTY FDA UDI
HTN FDA UDI
LXT FDA UDI
KTT FDA UDI
HRS FDA UDI
JDW FDA UDI
HWC FDA UDI
HSB FDA UDI
GMDN Term
External orthopaedic fixation system, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
888.3030 FDA UDI
888.3020 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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: External orthopaedic fixation system, single-use

Tempfix®rod Assembly by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External orthopaedic fixation system, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomet Orthopedics, Inc.

Sources (1)

  • FDA UDI 24f10f27-54b1-43fc-be81-91f1d9fa8567 35 fields · synced May 30, 2026