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Tempfix®ankle Transfixing Pin - Right

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name
TEMPFIX®ANKLE TRANSFIXING PIN - RIGHT FDA UDI
Generic Name
External orthopaedic fixation system, single-use, sterile FDA UDI
Model / Reference
8181-10-000 FDA UDI

Identifiers

Catalog Number
818110000 FDA UDI
Primary DI / UDI-DI
00887868047732 FDA UDI
FDA Product Code
JDW FDA UDI
HRS FDA UDI
HSB FDA UDI
HTY FDA UDI
HTN FDA UDI
KTT FDA UDI
HWC FDA UDI
LXT FDA UDI
GMDN Term
External orthopaedic fixation system, single-use, sterile 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

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: External orthopaedic fixation system, single-use, sterile

Tempfix®ankle Transfixing Pin - Right 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, sterile.

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 dfda5651-1763-4b27-b6ea-3c84a5e9975d 34 fields · synced Jun 1, 2026