Cartiva Synthetic Cartilage Implant CAR-10-US

GUDID 00852897002038

10 mm Synthetic Cartilage Implant

CARTIVA, INC

Total metatarsophalangeal joint prosthesis, one-piece
Primary Device ID00852897002038
NIH Device Record Key2be14285-d6f5-4d32-891a-4b511255f16d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCartiva Synthetic Cartilage Implant
Version Model NumberCAR-10-US
Catalog NumberCAR-10-US
Company DUNS078582549
Company NameCARTIVA, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net
Phone770-754-3800
Emailinfo@cartiva.net

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100852897002038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWDProsthesis, Toe, Hemi-, Phalangeal
PNWProsthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-06-23
Device Publish Date2017-01-13

On-Brand Devices [Cartiva Synthetic Cartilage Implant]

0085289700203810 mm Synthetic Cartilage Implant
008528970020218 mm Synthetic Cartilage Implant
0085289700233512 mm Synthetic Cartilage Implant
008528970023286 mm Synthetic Cartilage Implant
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