Prodisc C

GUDID 10705034763866

PRODISC-C IMPLANT EXTRA LARGE 7MM-STERILE

Centinel Spine, Inc.

Cervical total disc replacement prosthesis, sterile

• Primary Device ID: 10705034763866
• NIH Device Record Key: 4f9633cb-3691-474e-a1a5-661278cbaae3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prodisc C
• Version Model Number: 09.820.067S
• Company DUNS: 949024850
• Company Name: Centinel Spine, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843193112897 [Primary]
GS1	10705034763866 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P070001

FDA Product Code

• MJO: Prosthesis, Intervertebral Disc

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: 2018-11-16
• Device Publish Date: 2018-10-16

On-Brand Devices [Prodisc C]

• 10705034763897: PRODISC-C IMPLANT EXTRA LARGE DEEP 7MM-STERILE
• 10705034763880: PRODISC-C IMPLANT EXTRA LARGE DEEP 6MM-STERILE
• 10705034763873: PRODISC-C IMPLANT EXTRA LARGE DEEP 5MM-STERILE
• 10705034763866: PRODISC-C IMPLANT EXTRA LARGE 7MM-STERILE
• 10705034763859: PRODISC-C IMPLANT EXTRA LARGE 6MM-STERILE
• 10705034763842: PRODISC-C IMPLANT EXTRA LARGE 5MM-STERILE
• 10705034763835: PRODISC-C IMPLANT LARGE DEEP 7MM-STERILE
• 10705034763828: PRODISC-C IMPLANT LARGE DEEP 6MM-STERILE
• 10705034763811: PRODISC-C IMPLANT LARGE DEEP 5MM-STERILE
• 10705034763804: PRODISC-C IMPLANT LARGE 7MM-STERILE
• 10705034763798: PRODISC-C IMPLANT LARGE 6MM-STERILE
• 10705034763781: PRODISC-C IMPLANT LARGE 5MM-STERILE
• 10705034763774: PRODISC-C IMPLANT MEDIUM DEEP 7MM-STERILE
• 10705034763767: PRODISC-C IMPLANT MEDIUM DEEP 6MM-STERILE
• 10705034763750: PRODISC-C IMPLANT MEDIUM DEEP 5MM-STERILE
• 10705034763743: PRODISC-C IMPLANT MEDIUM 7MM-STERILE
• 10705034763736: PRODISC-C IMPLANT MEDIUM 6MM-STERILE
• 10705034763729: PRODISC-C IMPLANT MEDIUM 5MM-STERILE