Home GUDID M2482605151 Universal 2™ Total Wrist Implant System
Primary DI M2482605151
Brand Universal 2™ Total Wrist Implant System
Company Ascension Orthopedics, Inc.
Model 260515
Catalog number 260515
Device description Universal 2™ Total Wrist Implant System TRIAL SCREW 4/15MM
Published 2018-03-09
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name HWD STARTER, BONE SCREW
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HWD Starter, Bone Screw Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10381780279051 Primary GS1 0 M2482605151 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10381780279051 10381780279051
GMDN Terms# Term, Definition table Term Definition Orthopaedic bone screw starter/notcher A hand-held surgical instrument used to create an indentation or enlarge a pre-drilled pilot hole in a bone that will enable the surgeon to begin threading a bone screw or place another form of anchoring device. This device, commonly known as a bone notcher, may function and be used in a variety of ways: 1) notch the bone such that the threads on a bone screw will bite into the bone; 2) simply hold the screw at the desired angle to the bone while the screw is driven into position; or 3) in the case of hard bone (e.g., on the glenoid) be inserted into a pilot hole where it is rotated to create a cavity within the soft bone for placement of, e.g., a suture anchor. This is a reusable device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 942377524 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 true 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 00841731134752 Hintermann Series VILEX LLC HWD 2025-09-17 00840019968867 Dakota ALIF Plate System PRECISION SPINE, INC. HWD 2025-03-13 00840180529270 General Instruments ALPHATEC SPINE, INC. HWD 2024-08-01 B07315K0140200 NIDO Pedicle Screw System Kalitec Direct LLC HWD 2023-10-06 B07315K0160200 NIDO Pedicle Screw System Kalitec Direct LLC HWD 2023-10-06 00887868570940 Distal Screw Sheath Biomet Orthopedics, LLC HWD 2023-08-15 00887868570049 Distal Screw Biomet Orthopedics, LLC HWD 2023-06-13 00887868570124 Lag Screw Trochar Biomet Orthopedics, LLC HWD 2023-06-13 00887868570148 Affixus® Biomet Orthopedics, LLC HWD 2023-06-13 00887868570155 Anti-Rotation Screw Sheath Biomet Orthopedics, LLC HWD 2023-06-13 00887868570162 Anti-Rotation Screw Trochar Biomet Orthopedics, LLC HWD 2023-06-13 00887868570179 Anti-Rotation Screw Sleeve Biomet Orthopedics, LLC HWD 2023-06-13 00887868570186 Lag Screw Sheath Biomet Orthopedics, LLC HWD 2023-06-13 00887868570193 Lag Screw Sleeve Biomet Orthopedics, LLC HWD 2023-06-13 00887868570230 Lag Screw Tap Biomet Orthopedics, LLC HWD 2023-06-13 00887868570247 Distal Screw Trochar Biomet Orthopedics, LLC HWD 2023-06-13 00844856069756 Arsenal ALPHATEC SPINE, INC. HWD 2023-05-13 00190376477954 AMP-LTX ALPHATEC SPINE, INC. HWD 2023-04-27 00190376477961 AMP-LTX ALPHATEC SPINE, INC. HWD 2023-04-27 00190376477978 AMP-LTX ALPHATEC SPINE, INC. HWD 2023-04-27 00190376477985 AMP-LTX ALPHATEC SPINE, INC. HWD 2023-04-27 00885556864869 Universal2 Total Wrist Implant System Smith & Nephew, Inc. HWD 2023-01-19 00885556864876 Universal2 Total Wrist Implant System Smith & Nephew, Inc. HWD 2023-01-19 00885556864883 Universal2 Total Wrist Implant System Smith & Nephew, Inc. HWD 2023-01-19 00885556864890 Universal2 Total Wrist Implant System Smith & Nephew, Inc. HWD 2023-01-19 00885556864906 Universal2 Total Wrist Implant System Smith & Nephew, Inc. HWD 2023-01-19 04026575182572 LINK Instruments - Fixation instruments WALDEMAR LINK GmbH & Co. KG HWD 2022-12-27 04026575046768 Endo-Model Knee System - Instruments WALDEMAR LINK GmbH & Co. KG HWD 2022-12-20 04026575395521 SPARK - Instruments WALDEMAR LINK GmbH & Co. KG HWD 2022-12-16 04026575347698 LINK Instruments - Fixation instruments WALDEMAR LINK GmbH & Co. KG HWD 2022-12-15
integralife.com