Home GUDID 10806378015397
ACUMED
Primary DI 10806378015397
Brand ACUMED
Company Acumed LLC
Model 30-0022-S
Device description 27.5mm Acutrak 2 - 5.5 Screw
Published 2019-04-19
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true
Product Codes# Code, Name table Code Name HWC Screw, fixation, bone
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HWC Screw, Fixation, Bone Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10806378015397 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10806378015397 10806378015397
GMDN Terms# Term, Definition table Term Definition Craniofacial fixation plate, non-bioabsorbable A small, implantable sheet of firm material that is attached with screws to fractured craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material cannot be chemically degraded or absorbed by natural body processes [includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre]. The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation.
Regulatory Flags# DUNS number 196884852 Device count 1 Lot or batch true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05055662970890 ORTHO SOLUTIONS SUCCESSION AFN SYSTEM ORTHO SOLUTIONS HOLDINGS LIMITED HWC 2026-07-10 05055662971514 ORTHO SOLUTIONS SUCCESSION AFN SYSTEM ORTHO SOLUTIONS HOLDINGS LIMITED HWC 2026-07-10 00885556904879 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556904923 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906163 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906170 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906187 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906194 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906200 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906217 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906224 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906231 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906248 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906255 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906262 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906279 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906286 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906293 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906309 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906316 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906323 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556901946 EVOS Smith & Nephew, Inc. HWC 2026-06-24 00888867460973 Arthrex® ARTHREX, INC. HWC 2026-06-11 00193982586393 CAPTIVATE GLOBUS MEDICAL, INC. HWC 2026-06-10 00193982586416 CAPTIVATE GLOBUS MEDICAL, INC. HWC 2026-06-10 00193982586430 CAPTIVATE GLOBUS MEDICAL, INC. HWC 2026-06-10 00193982586454 CAPTIVATE GLOBUS MEDICAL, INC. HWC 2026-06-10 00193982586478 CAPTIVATE GLOBUS MEDICAL, INC. HWC 2026-06-10 00193982586690 CAPTIVATE GLOBUS MEDICAL, INC. HWC 2026-06-10 00193982586706 CAPTIVATE GLOBUS MEDICAL, INC. HWC 2026-06-10