Home GUDID M92843021 Collagen Meniscus Implant CMI®
Primary DI M92843021
Brand Collagen Meniscus Implant CMI®
Company IVY SPORTS MEDICINE LLC
Model Medial XL
Catalog number 4302
Published 2017-08-14
Public version status Update
Distribution status Not 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 OLC Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OLC Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M92843021 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Meniscus biomatrix implant, animal-derived A bioabsorbable animal-derived material intended to be implanted to fill a defect in a damaged meniscus for the reinforcement of the remaining meniscus, and to provide a porous scaffold (matrix) intended to be replaced by natural tissue. It is made of an animal-derived material (e.g., bovine or porcine collagen) and is implanted during a minimally-invasive arthroscopic surgical procedure after trimming to fit the measured defect; it is available in a variety of sizes. This device is not intended to replace the entire meniscus.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 046226406 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M92847011 SharpShooter® Surgical Suture 4701 4701 2015-10-24 M928HS47041 SharpShooter® Surgical Suture HS4704 HS4704 2015-10-24 M92843001 Collagen Meniscus Implant CMI® Medial 7.5 mm 4300 2015-10-24 M92843011 Collagen Meniscus Implant CMI® Medial 9.0 mm 4301 2015-10-24 M92847012 SharpShooter® Surgical Suture 4701 4701 2015-10-24 M92847201 Stryker AIR™ 4720 4720 2017-01-13 M92847301 IvyAIR Meniscus System, Curved 4730 4730 2016-08-05
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00813954026022 RejuvaKnee COLLAGEN MATRIX, INC. OLC 2024-11-04 00813954026039 RejuvaKnee COLLAGEN MATRIX, INC. OLC 2024-11-04 M92843001 Collagen Meniscus Implant CMI® IVY SPORTS MEDICINE LLC OLC 2015-10-24 M92843011 Collagen Meniscus Implant CMI® IVY SPORTS MEDICINE LLC OLC 2015-10-24
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