Cartiva SCI Introducer INT-08-US

GUDID 00852897002045

Surgical Instrument- 8 mm Introducer

CARTIVA, INC

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00852897002045
• NIH Device Record Key: e6e8eb77-2ff2-4fa8-a47e-84a934e029a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cartiva SCI Introducer
• Version Model Number: INT-08-US
• Catalog Number: INT-08-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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852897002045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150017

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00852897002045]

Moist Heat or Steam Sterilization

[00852897002045]

Moist Heat or Steam Sterilization

[00852897002045]

Moist Heat or Steam Sterilization

[00852897002045]

Moist Heat or Steam Sterilization

[00852897002045]

Moist Heat or Steam Sterilization

[00852897002045]

Moist Heat or Steam Sterilization

[00852897002045]

Moist Heat or Steam Sterilization

[00852897002045]

Moist Heat or Steam Sterilization

[00852897002045]

Moist Heat or Steam Sterilization

[00852897002045]

Moist Heat or Steam Sterilization

[00852897002045]

Moist Heat or Steam Sterilization

[00852897002045]

Moist Heat or Steam Sterilization

[00852897002045]

Moist Heat or Steam Sterilization

[00852897002045]

Moist Heat or Steam Sterilization

[00852897002045]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-13

On-Brand Devices [Cartiva SCI Introducer]

• 00852897002113: Surgical Instrument- 10 mm Introducer
• 00852897002106: Surgical Instrument- 8 mm Introducer
• 00852897002052: Surgical Instrument- 10 mm Introducer
• 00852897002045: Surgical Instrument- 8 mm Introducer
• 00852897002977: Surgical Instrument- 6 mm Introducer
• 00852897002946: Surgical Instrument- 12 mm Introducer