Home GUDID 00810111227292
K-Wire
Primary DI 00810111227292
Brand K-Wire
Company Treace Medical Concepts, Inc.
Model 02-00543
Device description 2.8MM x 178MM K-WIRE
Published 2026-06-02
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810111227292 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00810111227292 00810111227292 810111227292 0810111227292
GMDN Terms# Term, Definition table Term Definition Orthopaedic intraoperative positioning pin, single-use A nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a single-use device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 054808082 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00842078125724 Carilaginator EXTREMITY MEDICAL, LLC HWE 2026-06-09 00842078125748 Carilaginator EXTREMITY MEDICAL, LLC HWE 2026-06-09 00842078130261 Carilaginator EXTREMITY MEDICAL, LLC HWE 2026-06-09 00842078130315 Carilaginator EXTREMITY MEDICAL, LLC HWE 2026-06-09 00842078130452 Carilaginator EXTREMITY MEDICAL, LLC HWE 2026-06-09 00842078130490 Carilaginator EXTREMITY MEDICAL, LLC HWE 2026-06-09 00842078130537 Carilaginator EXTREMITY MEDICAL, LLC HWE 2026-06-09 00842078134054 Carilaginator EXTREMITY MEDICAL, LLC HWE 2026-06-09 00842078134061 Carilaginator EXTREMITY MEDICAL, LLC HWE 2026-06-09 00842078134078 Carilaginator EXTREMITY MEDICAL, LLC HWE 2026-06-09 00842078134085 Carilaginator EXTREMITY MEDICAL, LLC HWE 2026-06-09 00842078134092 Carilaginator EXTREMITY MEDICAL, LLC HWE 2026-06-09 00842078134108 Carilaginator EXTREMITY MEDICAL, LLC HWE 2026-06-09 00842078134115 Carilaginator EXTREMITY MEDICAL, LLC HWE 2026-06-09 00850078396303 PFT Adapter, SYK, Virata, 85 in-lb (228-TXRX-006) Eca Medical Instruments HWE 2026-06-05 00850078396310 PFT Adapter, SYK, Mariner, 105 in-lb (228-TXRX-007) Eca Medical Instruments HWE 2026-06-05 10705034647807 TRIALTIS Medos International Sàrl HWE 2026-06-03 10705034647814 TRIALTIS Medos International Sàrl HWE 2026-06-03 10705034647821 TRIALTIS Medos International Sàrl HWE 2026-06-03 10705034647838 TRIALTIS Medos International Sàrl HWE 2026-06-03 10705034648118 TRIALTIS Medos International Sàrl HWE 2026-06-03 07613327648331 PANGEA Stryker GmbH HWE 2026-06-02 07613327648362 PANGEA Stryker GmbH HWE 2026-06-02 07613327652703 N/A STRYKER CORPORATION HWE 2026-04-15 07613327652710 PROstep STRYKER CORPORATION HWE 2026-04-13 07613327652727 N/A STRYKER CORPORATION HWE 2026-04-13 07613327652734 N/A STRYKER CORPORATION HWE 2026-04-13 07613327652741 N/A STRYKER CORPORATION HWE 2026-03-25 07613327652758 N/A STRYKER CORPORATION HWE 2026-03-25 07613327652789 N/A STRYKER CORPORATION HWE 2026-03-25