Home GUDID B504SRAR16922N0 Arthrex
Primary DI B504SRAR16922N0
Brand Arthrex
Company Provision
Model AR-16922N
Published 2019-01-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name LHX Trousers, Anti-Shock
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LHX Trousers, Anti-Shock Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B504SRAR16922N0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Suturing unit, reprocessed A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft; it may in addition knot and/or cut the sutures as they are placed. This is a previously used single-use device that has been processed for an additional single-use patient application.
Regulatory Flags# DUNS number 016889401 Device count 1 DM exempt true 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 true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00198506089589 ELMED INCORPORATED ELMED INCORPORATED LHX 2026-03-13 00198506089596 ELMED INCORPORATED ELMED INCORPORATED LHX 2026-03-13 00885556919620 R3 Smith & Nephew, Inc. LHX 2024-11-06 00885556919613 R3 Smith & Nephew, Inc. LHX 2024-11-04 00191083047300 AlloWedge Rti Surgical, Inc. LHX 2024-10-14 00191083047317 AlloWedge Rti Surgical, Inc. LHX 2024-10-14 00191083047324 AlloWedge Rti Surgical, Inc. LHX 2024-10-14 00191083047331 AlloWedge Rti Surgical, Inc. LHX 2024-10-14 00191083047348 AlloWedge Rti Surgical, Inc. LHX 2024-10-14 00191083047355 AlloWedge Rti Surgical, Inc. LHX 2024-10-14 00191083047362 AlloWedge Rti Surgical, Inc. LHX 2024-10-14 00191083047379 AlloWedge Rti Surgical, Inc. LHX 2024-10-14 00840343722876 GEN2 SURGIX MEDICAL LLC LHX 2024-06-28 08800017205267 LOSPA Knee System, EXULT Knee System Corentec Co., Ltd LHX 2024-01-12 08800068981486 LOSPA Knee System, EXULT Knee System Corentec Co., Ltd LHX 2024-01-12 00840343720537 GEN2 SURGIX MEDICAL LLC LHX 2023-12-15 00840343720957 GEN2 SURGIX MEDICAL LLC LHX 2023-12-15 10889981321390 Specials Seaspine Orthopedics Corporation LHX 2023-12-06 00840343719326 Gen2 SURGIX MEDICAL LLC LHX 2023-11-14 00840343719364 Gen2 SURGIX MEDICAL LLC LHX 2023-11-14 00885556910757 Legion Smith & Nephew, Inc. LHX 2023-09-06 00840019967655 Reform® Ti CT Modular MIS Pedicle Screw System PRECISION SPINE, INC. LHX 2023-08-07 00885556832417 Salto Talaris Total Ankle Prosthesis Smith & Nephew, Inc. LHX 2023-08-02 10889981308315 Specials Seaspine Orthopedics Corporation LHX 2023-03-24 10889981308322 Specials Seaspine Orthopedics Corporation LHX 2023-03-24 10889981308339 Specials Seaspine Orthopedics Corporation LHX 2023-03-24 10889981308346 Specials Seaspine Orthopedics Corporation LHX 2023-03-24 10889981308353 Specials Seaspine Orthopedics Corporation LHX 2023-03-24 10889981308438 Specials Seaspine Orthopedics Corporation LHX 2023-03-24 00850005827337 GENESIS AWL/TAPPER Genesis Biologics, Inc. LHX 2023-03-16