AccessGUDID - DEVICE: Cartiva Synthetic Cartilage Implant (00852897002328)

GUDID

Device Identifier (DI) Information

Brand Name: Cartiva Synthetic Cartilage Implant
Version or Model: CAR-06-US
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CAR-06-US
Company Name: CARTIVA, INC

Primary DI Number: 00852897002328
Issuing Agency: GS1
Commercial Distribution End Date: October 17, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 078582549 *Terms of Use

Device Description: 6 mm Synthetic Cartilage Implant

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?
33700	Total metatarsophalangeal joint prosthesis, one-piece	An implantable device designed to replace the metatarsophalangeal (MTP) joint(s) of the foot (toe). The device is made of a single piece of silicone elastomer. It is is intended to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PNW	Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

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
Handling Environment Temperature: between 0 and 49 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a79aa74a-ebca-4066-b53b-cc83125b9bed
Public Version Date: November 15, 2024
Public Version Number: 3
DI Record Publish Date: December 13, 2019