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Other External Fixation

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
OTHER EXTERNAL FIXATION FDA UDI
Generic Name
External orthopaedic fixation system, single-use FDA UDI
Device Name
STEINMAN PIN TROCAR PT ROUND END 5/64 X 9 FDA UDI
Model / Reference
128079 FDA UDI
Description
STEINMAN PIN TROCAR PT ROUND END 5/64 X 9 FDA UDI

Identifiers

Catalog Number
128079 FDA UDI
Primary DI / UDI-DI
03596010082763 FDA UDI
FDA Product Code
HTY 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
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

Yes

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

Other External Fixation by Smith & Nephew, 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
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI 721805af-7772-449a-b8f9-44c1d589dc36 35 fields · synced Jun 8, 2026