Home GUDID 10850003396214 FLEXBAND FIX
Primary DI 10850003396214
Brand FLEXBAND FIX
Company Artelon
Model 51013
Device description FLEXBAND and anchor kit with paddle handle
Published 2023-05-24
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 MBI Fastener, Fixation, Nondegradable, Soft Tissue QWJ Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic 2 QWJ Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10850003396214 Package GS1 5 In Commercial Distribution 00850003396217 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 10850003396214 10850003396214 00850003396217 00850003396217 850003396217 0850003396217
GMDN Terms# Term, Definition table Term Definition Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable An implantable material (e.g., flat sheet) made from a bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.
Device Sizes# Type, Value, Unit table Type Value Unit Length 10 Centimeter
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 066284070 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number true Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 00860016070004 ICONN Revolution 6.5MM Knotless Suture Anchor ICONN ORTHOPEDICS LLC MBI 2026-07-16 10810128462867 VersiTILT 2.4 x 8.5mm Implant System T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION MBI 2026-07-16 10810128462874 VersiTILT 2.4 x 8.5mm Button and Inserter T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION MBI 2026-07-16 10810128462881 VersiTILT Drill Pin, 3.1mm T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION MBI 2026-07-16 10810128462898 VersiTILT Button, 2.4x8.5mm T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION MBI 2026-07-16 10810128462904 VersiTILT 2.4x12mm Implant System, Long T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION MBI 2026-07-16 10810128462911 VersiTILT 2.4x12mm Button and Inserter, Long T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION MBI 2026-07-16 10810128462928 VersiTILT Button, 2.4x12mm T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION MBI 2026-07-16 10810128462935 VersiTILT 3.1x10.9mm Implant System, XL T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION MBI 2026-07-16 10810128462942 VersiTILT 3.1x10.9mm Button and Inserter, XL T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION MBI 2026-07-16 10810128462959 VersiTILT Drill Pin, 3.6mm T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION MBI 2026-07-16 10810128462966 VersiTILT Button, 3.1x10.9mm T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION MBI 2026-07-16 09353903030225 OCTOPi Suture Anchor System FIELD ORTHOPAEDICS PTY LTD MBI 2026-07-15 09353903030317 OCTOPi Suture Anchor System FIELD ORTHOPAEDICS PTY LTD MBI 2026-07-15 09353903030324 OCTOPi Suture Anchor System FIELD ORTHOPAEDICS PTY LTD MBI 2026-07-15 00810155331412 Tigon Medical Tigon Medical LLC MBI 2026-07-09 00850029805106 Tigon Medical Tigon Medical LLC MBI 2026-06-26 07901125601130 GMReis Suture Anchors GM DOS REIS INDUSTRIA E COMERCIO LTDA MBI 2026-06-25 09353903030201 Griplasty System FIELD ORTHOPAEDICS PTY LTD MBI 2026-06-24 00860013918606 ArthroTAK Tendon Anchor Kit ARTHROTAK, LLC MBI 2026-06-08 00860013918613 ArthroTAK Tendon Anchor Kit ARTHROTAK, LLC MBI 2026-06-08 00860013918620 ArthroTAK Tendon Anchor Kit ARTHROTAK, LLC MBI 2026-06-08 00860013918637 ArthroTAK Tendon Anchor Kit ARTHROTAK, LLC MBI 2026-06-08 08720629959573 SINEFIX Baat Medical Products B.V. MBI 2026-04-01 08721515510151 SINEFIX Baat Medical Products B.V. MBI 2026-04-01 08101755018820 Hercules In2Bones USA, LLC MBI 2026-03-30 08437019739744 QuadLock™ Fixation System 9mm ABANZA TECNOMED SL. MBI 2026-01-14 08437019739751 QuadLock™ Fixation System 10mm ABANZA TECNOMED SL. MBI 2026-01-14 08437019739768 QuadLock™ Fixation System 11mm ABANZA TECNOMED SL. MBI 2026-01-14 00888867465220 Arthrex® ARTHREX, INC. MBI 2025-06-23
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