Home GUDID B504SRPC1000 Avitus Orthopaedics
Primary DI B504SRPC1000
Brand Avitus Orthopaedics
Company Provision
Model PC-100
Published 2023-05-18
Public version status New
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 HWJ Awl
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HWJ Awl Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B504SRPC1000 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 may also knot, cut and/or tighten the sutures/ligature loop during or after placement. 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. 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 00840311245376 Streamline MIS Spinal Fixation System Xtant Medical Holdings, Inc. HWJ 2026-04-30 04048844406547 n/a implantcast GmbH HWJ 2026-04-07 04052536216161 uCentum Ulrich GmbH & Co. KG HWJ 2026-03-31 00860015151308 EnFix Instrument Kit - Complete TETROUS, INC. HWJ 2026-02-24 00887868287473 Trinica ALP Anterior Lumbar Plate System Highridge Medical, LLC HWJ 2025-11-12 03662663108126 Trinica/Trinica Select Anterior Cervical Plate System Highridge Medical, LLC HWJ 2025-11-12 03662663109949 InViZia Anterior Cervical Plate System Highridge Medical, LLC HWJ 2025-11-12 03662663128759 PathFinder NXT Minimally Invasive Pedicle Screw System Highridge Medical, LLC HWJ 2025-11-12 03662663129015 Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation System Highridge Medical, LLC HWJ 2025-11-12 07640375234773 SCARLET AL-T INSTRUMENTATION SpineArt SA HWJ 2025-11-10 08059386744338 Orthopaedic Surgical Instruments CITIEFFE SRL HWJ 2025-11-06 00763000674410 n/a MEDTRONIC SOFAMOR DANEK, INC. HWJ 2025-10-26 09120129291507 Awl, Curved, Cannulated I.T.S. GmbH HWJ 2025-10-21 09120129291514 Awl Trocar I.T.S. GmbH HWJ 2025-10-21 00763000878245 n/a MEDTRONIC SOFAMOR DANEK, INC. HWJ 2025-10-20 00840180541050 General Instruments ALPHATEC SPINE, INC. HWJ 2025-10-17 00763000885243 n/a MEDTRONIC SOFAMOR DANEK, INC. HWJ 2025-10-11 00816342025522 AWL PARCUS MEDICAL LLC HWJ 2025-09-16 04047844128190 CYLOX ST SIGNUS Medizintechnik GmbH HWJ 2025-05-27 04047844128206 CYLOX ST SIGNUS Medizintechnik GmbH HWJ 2025-05-27 00841732134393 GENERIC Surgical Instruments CTL Medical Corporation HWJ 2023-10-07 00841732134409 GENERIC Surgical Instruments CTL Medical Corporation HWJ 2023-10-07 00841732134416 GENERIC Surgical Instruments CTL Medical Corporation HWJ 2023-10-07 00841732134423 GENERIC Surgical Instruments CTL Medical Corporation HWJ 2023-10-07 00841732135406 GENERIC Surgical Instruments CTL Medical Corporation HWJ 2023-10-07 00841732139411 GENERIC Surgical Instruments CTL Medical Corporation HWJ 2023-10-07 00841732139428 GENERIC Surgical Instruments CTL Medical Corporation HWJ 2023-10-07 00841732163850 GENERIC Surgical Instruments CTL Medical Corporation HWJ 2023-09-14 00841732163935 GENERIC Surgical Instruments CTL Medical Corporation HWJ 2023-09-14 00810074756037 4WEB Medical 4web Medical HWJ 2023-02-13