Home GUDID 10814493010661
AcuTie II
Primary DI 10814493010661
Brand AcuTie II
Company ACUTE INNOVATIONS LLC
Model STW1104
Device description AcuTie Two Sternum Plate
Published 2015-09-16
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true
Product Codes# Code, Name table Code Name HWC Screw, Fixation, Bone JDQ Cerclage, Fixation KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HWC Screw, Fixation, Bone Orthopedic 2 JDQ Cerclage, Fixation Orthopedic 2 KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10814493010661 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10814493010661 10814493010661
GMDN Terms# Term, Definition table Term Definition Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile A non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 619225415 Device count 1 Premarket exempt true Lot or batch true 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 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 00195377108555 PRECICE NUVASIVE SPECIALIZED ORTHOPEDICS, INC. HWC 2023-10-04 00195377108562 PRECICE NUVASIVE SPECIALIZED ORTHOPEDICS, INC. HWC 2023-10-04 00195377108579 PRECICE NUVASIVE SPECIALIZED ORTHOPEDICS, INC. HWC 2023-10-04 00195377108586 PRECICE NUVASIVE SPECIALIZED ORTHOPEDICS, INC. HWC 2023-10-04 00195377108593 PRECICE NUVASIVE SPECIALIZED ORTHOPEDICS, INC. HWC 2023-10-04 00195377108609 PRECICE NUVASIVE SPECIALIZED ORTHOPEDICS, INC. HWC 2023-10-04 00195377108623 PRECICE NUVASIVE SPECIALIZED ORTHOPEDICS, INC. HWC 2023-10-04 00195377108630 PRECICE NUVASIVE SPECIALIZED ORTHOPEDICS, INC. HWC 2023-10-04 00195377108647 PRECICE NUVASIVE SPECIALIZED ORTHOPEDICS, INC. HWC 2023-10-04 00195377108654 PRECICE NUVASIVE SPECIALIZED ORTHOPEDICS, INC. HWC 2023-10-04