Home GUDID 00810028396142 EF1
Primary DI 00810028396142
Brand EF1
Company Medshape, Inc.
Model DNE-6012-019A
Device description Collet - 3mm - Black
Published 2024-05-31
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810028396142 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 00810028396142 00810028396142 810028396142 0810028396142
GMDN Terms# Term, Definition table Term Definition External orthopaedic fixation system noninvasive component, single-use A noninvasive, non-powered structural component of an external orthopaedic fixation system intended for bone/joint treatment (typically fracture stabilization, deformity correction, or distraction), in conjunction with an invasive bone pin (not included). It is in the form of a full or partial ring, rod (e.g., straight, curved, telescopic), plate, or connector (e.g., screw, bolt, nut, hinge, coupling, fastener); it is not a surgical instrument. This is a single-use device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 601306413 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false 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 07613327616859 HOFFMANN LRF Stryker GmbH KTT 2026-07-23 07613327616880 HOFFMANN LRF Stryker GmbH KTT 2026-07-23 07613327616835 HOFFMANN LRF Stryker GmbH KTT 2026-07-21 07613327616866 HOFFMANN LRF Stryker GmbH KTT 2026-07-21 00889795154620 Spider Monkey Bone Transport System Paragon 28, Inc. KTT 2026-06-10 00889795154637 Spider Monkey Bone Transport System Paragon 28, Inc. KTT 2026-06-10 00889795154644 Spider Monkey Bone Transport System Paragon 28, Inc. KTT 2026-06-10 00889795154651 Spider Monkey Bone Transport System Paragon 28, Inc. KTT 2026-06-10 10888867544571 Arthrex® ARTHREX, INC. KTT 2026-03-13 10886982346872 MAXFRAME Synthes GmbH KTT 2025-01-29 00810028396166 EF1 Medshape, Inc. KTT 2024-07-09 00810028396159 EF1 Medshape, Inc. KTT 2024-05-31 00810028396173 EF1 Medshape, Inc. KTT 2024-05-31 10886982338778 MAXFRAME SYNTHES (U.S.A.) LP KTT 2024-02-05 10886982343710 MAXFRAME Synthes GmbH KTT 2024-01-04 10886982343727 MAXFRAME Synthes GmbH KTT 2024-01-04 10886982343734 MAXFRAME Synthes GmbH KTT 2024-01-04 10886982338570 MAXFRAME SYNTHES (U.S.A.) LP KTT 2022-04-26 10886982338587 MAXFRAME SYNTHES (U.S.A.) LP KTT 2022-04-26 10886982338594 MAXFRAME SYNTHES (U.S.A.) LP KTT 2022-04-26 10886982338600 MAXFRAME SYNTHES (U.S.A.) LP KTT 2022-04-26 00841132142325 eZ-Fix ORTHOPEDIATRICS CORP. KTT 2020-02-28 00841132142905 eZ-Fix ORTHOPEDIATRICS CORP. KTT 2020-02-28 00841132142950 eZ-Fix ORTHOPEDIATRICS CORP. KTT 2020-02-28 00841132143025 eZ-Fix ORTHOPEDIATRICS CORP. KTT 2020-02-28 07613327079241 HOFFMANN Stryker GmbH KTT 2018-09-24 07613327079272 HOFFMANN Stryker GmbH KTT 2018-09-24 07613327079333 HOFFMANN Stryker GmbH KTT 2018-09-24 07613327079395 HOFFMANN Stryker GmbH KTT 2018-09-24 07613327079401 HOFFMANN Stryker GmbH KTT 2018-09-24