Home GUDID 00857915007132 Stratos
Primary DI 00857915007132
Brand Stratos
Company A.M. SURGICAL, INC.
Model 5500
Device description Endoscopic Release System (GEN1)
Published 2019-07-17
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 NBH Accessories, Arthroscopic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NBH Accessories, Arthroscopic Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00857915007156 Package GS1 5 In Commercial Distribution 00857915007132 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 00857915007156 00857915007156 857915007156 0857915007156 00857915007132 00857915007132 857915007132 0857915007132
GMDN Terms# Term, Definition table Term Definition Hand ligament surgical release instrument A hand-held manual surgical instrument designed for use during percutaneous/mini-open surgery to cut a ligament of the hand causing pathological compression. It is typically probe-like in form with a cutting element (e.g., blade, toothed wire) and is typically dedicated to a specific procedure (e.g., carpal tunnel release, trigger finger release). This is a single-use device.
Regulatory Flags# DUNS number 160020087 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true 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 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
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