AccessGUDID - DEVICE: RejuvaKnee (00813954026039)

GUDID

Device Identifier (DI) Information

Brand Name: RejuvaKnee
Version or Model: REJ090
Commercial Distribution Status: In Commercial Distribution
Catalog Number: REJ090
Company Name: COLLAGEN MATRIX, INC.

Primary DI Number: 00813954026039
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 176262442 *Terms of Use

Device Description: Collagen Meniscus Implant

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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 36 and 77 Degrees Fahrenheit
Storage Environment Temperature: between 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Large (9mm x 5mm)

Device Record Status

Public Device Record Key: 840d3843-00e3-4e51-8261-ebb24dedad18
Public Version Date: November 12, 2024
Public Version Number: 1
DI Record Publish Date: November 04, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: (201) 405-1477
Email: contact@regenity.com

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