Home GUDID B504SRAR16991N0 Arthrex
Primary DI B504SRAR16991N0
Brand Arthrex
Company Provision
Model AR-16991N
Published 2019-01-24
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 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 B504SRAR16991N0 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 Lot or batch true Manufacturing date on label true Expiration date on label true 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