Cartiva Synthetic Cartilage Implant CAR-06-US

GUDID 00852897002328

Total metatarsophalangeal joint prosthesis, one-piece

Primary Device ID	00852897002328
NIH Device Record Key	a79aa74a-ebca-4066-b53b-cc83125b9bed
Commercial Distribution Status	In Commercial Distribution
Brand Name	Cartiva Synthetic Cartilage Implant
Version Model Number	CAR-06-US
Catalog Number	CAR-06-US
Company DUNS	078582549
Company Name	CARTIVA, INC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Handling Environment Temperature	Between 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 49 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00852897002328 [Primary]

PNW	Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

Steralize Prior To Use	false
Device Is Sterile	true

00852897002038	10 mm Synthetic Cartilage Implant
00852897002021	8 mm Synthetic Cartilage Implant
00852897002335	12 mm Synthetic Cartilage Implant
00852897002328	6 mm Synthetic Cartilage Implant