Home GUDID 00816342020718 Accessories, arthroscopic
Primary DI 00816342020718
Brand Accessories, arthroscopic
Company PARCUS MEDICAL LLC
Model 10107
Device description Graft Station Tray
Published 2022-12-06
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name KQZ Component, Traction, Non-Invasive NBH Accessories, arthroscopic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KQZ Component, Traction, Non-Invasive Orthopedic 1 NBH Accessories, Arthroscopic Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816342020718 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00816342020718 00816342020718 816342020718 0816342020718
GMDN Terms# Term, Definition table Term Definition Tendon/ligament graft preparation station An assembly of devices designed to provide the operator with a workstation for the preparation and pretensioning of a ligament and/or tendon graft prior to implantation. It typically consists of a work base to provide a stable platform on which the graft can be treated, various types of adjustable and fixed posts including soft tissue clamps and tensioning devices, a graft sizing block, and tools to hold and tension a graft (e.g., an Allen key). It may be used for a variety of bone-tendon-bone and soft tissue grafts such as semitendinosus patellar tendon, quadriceps tendon, or patellar tendon grafts for anterior cruciate ligament (ACL) reconstruction. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 859961950 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label 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 00888867568280 Arthrex® ARTHREX, INC. NBH 2026-10-16 00888867568297 Arthrex® ARTHREX, INC. NBH 2026-10-16 00888867568303 Arthrex® ARTHREX, INC. NBH 2026-10-16 00888867568310 Arthrex® ARTHREX, INC. NBH 2026-10-16 00888867568457 Arthrex® ARTHREX, INC. NBH 2026-10-16 B382SD4830070 Surgical Direct Surgical Direct, Inc. NBH 2026-10-15 B382SD4840320 Surgical Direct Surgical Direct, Inc. NBH 2026-10-15 B382SD18146S90 Surgical Direct Surgical Direct, Inc. NBH 2026-10-13 B382SD316490 Surgical Direct Surgical Direct, Inc. NBH 2026-10-13 B382SD316690 Surgical Direct Surgical Direct, Inc. NBH 2026-10-13 B382SD316890 Surgical Direct Surgical Direct, Inc. NBH 2026-10-13 B382SD4810320 Surgical Direct Surgical Direct, Inc. NBH 2026-10-13 B382SD482014PH0 Surgical Direct Surgical Direct, Inc. NBH 2026-10-13 B382SD482036PH0 Surgical Direct Surgical Direct, Inc. NBH 2026-10-13 B382SD4843590 Surgical Direct Surgical Direct, Inc. NBH 2026-10-13 B382SD488200810 Surgical Direct Surgical Direct, Inc. NBH 2026-10-13 00888867620964 Arthrex® ARTHREX, INC. NBH 2026-10-12 00888867620971 Arthrex® ARTHREX, INC. NBH 2026-10-12 00888867620988 Arthrex® ARTHREX, INC. NBH 2026-10-12 00888867620995 Arthrex® ARTHREX, INC. NBH 2026-10-12 00190776434021 Millennium Avalign Technologies, Inc. NBH 2026-10-09 00190776434106 Millennium Avalign Technologies, Inc. NBH 2026-10-09 00190776433680 Millennium Avalign Technologies, Inc. NBH 2026-10-07 00190776433123 Millennium Avalign Technologies, Inc. NBH 2026-10-01 04055207071786 NA Richard Wolf GmbH NBH 2026-10-01 04055207071830 NA Richard Wolf GmbH NBH 2026-10-01 00190776431495 Millennium Avalign Technologies, Inc. NBH 2026-09-22 00190776432119 Millennium Avalign Technologies, Inc. NBH 2026-09-22 00190776431136 Millennium Avalign Technologies, Inc. NBH 2026-09-21 00190776431143 Millennium Avalign Technologies, Inc. NBH 2026-09-21