Simpex Kirschner Wire

FDA UDI

Class II (US FDA UDI)

by Simpex Medical, Inc.

Identity

Trade Name: Simpex Kirschner Wire FDA UDI
Generic Name: Orthopaedic bone wire FDA UDI
Device Name: Smooth K-Wire, Single Trocar Tip; .054" DIA x 4" LG; Material: 316L Stainless Steel FDA UDI
Model / Reference: TK-054-4S FDA UDI
Description: Smooth K-Wire, Single Trocar Tip; .054" DIA x 4" LG; Material: 316L Stainless Steel FDA UDI

Identifiers

Catalog Number: TK-054-4S FDA UDI
Primary DI / UDI-DI: B068TK0544S1 FDA UDI
510(k) Number: K911505 FDA UDI
FDA Product Code: HTY FDA UDI
GMDN Term: Orthopaedic bone wire 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

FDA UDI

Single Use

Yes

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

Dimensions & Sizes

Size: Length — 102 Millimeter FDA UDI
Outer Diameter — 1.4 Millimeter FDA UDI

Category: Orthopaedic bone wire

Simpex Kirschner Wire by Simpex Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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: Simpex Medical, Inc.

Sources (1)

FDA UDI fc5bb335-03de-4e73-8a37-d9e0c3ba2060 37 fields · synced Jun 8, 2026