Kmedic

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: KMEDIC FDA UDI
Generic Name: Orthopaedic bone pin, non-bioabsorbable FDA UDI
Device Name: K-WIRE D.TROCAR PT.12".045" 1.1MM (6PK) FDA UDI
Model / Reference: IPN015774 FDA UDI
Description: K-WIRE D.TROCAR PT.12".045" 1.1MM (6PK) FDA UDI

Identifiers

Catalog Number: KM71122 FDA UDI
Primary DI / UDI-DI: 24026704292640 FDA UDI
510(k) Number: K030336 FDA UDI
FDA Product Code: HTY FDA UDI
GMDN Term: Orthopaedic bone pin, non-bioabsorbable 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

FDA UDI

Implantable

Yes

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

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 12 Inch FDA UDI
Width — 1.1 Millimeter FDA UDI

Category: Orthopaedic bone pin, non-bioabsorbable

Kmedic by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone pin, non-bioabsorbable.

Steinmann Pins, K-Wire, smooth — Gebr. Brasseler GmbH & Co. KG · Class II
KW03-310-18.A — newbox medical GmbH · Class IIb
Steinmann Pins, K-Wire, smooth — Gebr. Brasseler GmbH & Co. KG · Class II
IlluminOss — ILLUMINOSS MEDICAL INC. · Class II
XtraFix® External Fixation System — Zimmer, Inc. · Class II
CALIBRATED GUIDE WIRE, THREADED TROCAR POINT — Biomet Orthopedics, Inc. · Class II
TRAUMA FIXATION SYSTEMS — Biomet Orthopedics, Inc. · Class II
SMART TSF — Smith & Nephew, Inc. · Class II

Cleared under the same submission

K030336 also covers:

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Teleflex Incorporated

Sources (1)

FDA UDI 929da3bb-1768-4ad7-9881-8b81f3b590a9 36 fields · synced May 30, 2026