Cartiva Synthetic Cartilage Implant CAR-06-US

GUDID 00852897002328

6 mm Synthetic Cartilage Implant

CARTIVA, INC

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

Customer Support Contacts

• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net
• Phone: 770-754-3800
• Email: info@cartiva.net

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852897002328 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150017

FDA Product Code

• PNW: Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-23
• Device Publish Date: 2019-12-13

On-Brand Devices [Cartiva Synthetic Cartilage Implant]

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