AccessGUDID - DEVICE: Collagen Meniscus Implant CMI® (M92843011)

GUDID

Device Identifier (DI) Information

Brand Name: Collagen Meniscus Implant CMI®
Version or Model: Medial 9.0 mm
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4301
Company Name: IVY SPORTS MEDICINE LLC

Primary DI Number: M92843011
Issuing Agency: HIBCC
Commercial Distribution End Date: August 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 046226406 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
59099	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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OLC	Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Medial 9.0 mm

Device Record Status

Public Device Record Key: a7e2a0cb-0d3e-49b0-a6b4-aa9e0290e2d7
Public Version Date: November 23, 2021
Public Version Number: 5
DI Record Publish Date: October 24, 2015