Prodisc L

GUDID 10705034700144

POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-12MM-STERILE

Centinel Spine, Inc.

Lumbar total disc replacement prosthesis

• Primary Device ID: 10705034700144
• NIH Device Record Key: 2a217e67-c4a1-4446-a059-264d90d5a92f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prodisc L
• Version Model Number: PDL-M-PT12S
• 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	00843193111777 [Primary]
GS1	10705034700144 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P050010

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 L]

• 10705034700182: SUPERIOR END PLATE MEDIUM 11°-STERILE
• 10705034700175: SUPERIOR END PLATE MEDIUM 6°-STERILE
• 10705034700151: POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-14MM-STERILE
• 10705034700144: POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-12MM-STERILE
• 10705034700137: POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-10MM-STERILE
• 10705034700106: INFERIOR END PLATE MEDIUM-STERILE
• 10705034700090: SUPERIOR END PLATE LARGE 11°-STERILE
• 10705034700083: SUPERIOR END PLATE LARGE 6°-STERILE
• 10705034700069: POLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-14MM-STERILE
• 10705034700052: POLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-12MM-STERILE
• 10705034700045: POLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-10MM-STERILE
• 00843193114983: SUPERIOR ENDPLATE MEDIUM 3°-STERILE
• 00843193114976: INFERIOR ENDPLATE MEDIUM 8°-STERILE
• 00843193114969: INFERIOR ENDPLATE MEDIUM 3°-STERILE
• 00843193114952: SUPERIOR ENDPLATE LARGE 3° -STERILE
• 00843193114945: INFERIOR ENDPLATE LARGE 8°-STERILE
• 00843193114938: INFERIOR ENDPLATE LARGE 3°-STERILE
• 00843193111692: INFERIOR END PLATE LARGE-STERILE