NovoStitch

GUDID 00853541006112

NovoStitch Pro Meniscal Repair System

Ceterix Orthopaedics

Arthroscopic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00853541006112
• NIH Device Record Key: f5916c52-9e32-4519-ac6a-0ab20551bbc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovoStitch
• Version Model Number: CTX-A003
• Company DUNS: 054774944
• Company Name: Ceterix Orthopaedics
• 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: true
• 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: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: 1-650-241-1748
• Email: info@ceterix.com
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853541006112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180531

FDA Product Code

• GAT: Suture, Nonabsorbable, Synthetic, Polyethylene

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-07

On-Brand Devices [NovoStitch]

• 00853541006167: NovoStitch Disposable Suture Passer
• 00853541006112: NovoStitch Pro Meniscal Repair System
• 00853541006105: NovoStitch Meniscal Repair Cartridge
• 00853541006082: NovoStitch Plus Meniscal Repair System
• 00853541006068: NovoStitch Meniscal Repair Cartridge, Size 0
• 00853541006051: NovoStitch Pro Meniscal Repair System, CTX-A004 (Size 0)