ShurFit CRT Peek Cage CRTP10-05

GUDID 00840019908832

CRT Peek 10 degree x 05mm

PRECISION SPINE, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840019908832
• NIH Device Record Key: 8bf8003f-02bd-4b82-b1e1-0c56c419369e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ShurFit CRT Peek Cage
• Version Model Number: CRTP10-05
• Catalog Number: CRTP10-05
• Company DUNS: 079398589
• Company Name: PRECISION SPINE, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840019908832 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060132

FDA Product Code

• JDK: Prosthesis, Hip, Cement Restrictor

Sterilization

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

[00840019908832]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-04-12

On-Brand Devices [ShurFit CRT Peek Cage]

• 00840019908900: CRT Peek 10 degree x 12mm
• 00840019908894: CRT Peek 10 degree x 11mm
• 00840019908887: CRT Peek 10 degree x 10mm
• 00840019908870: CRT Peek 10 degree x 09mm
• 00840019908863: CRT Peek 10 degree x 08mm
• 00840019908856: CRT Peek 10 degree x 07mm
• 00840019908849: CRT Peek 10 degree x 06mm
• 00840019908832: CRT Peek 10 degree x 05mm
• 00840019908825: CRT Peek 5 degree x 12mm
• 00840019908818: CRT Peek 5 degree x 11mm
• 00840019908801: CRT Peek 5 degree x 10mm
• 00840019908795: CRT Peek 5 degree x 9mm
• 00840019908788: CRT Peek 5 degree x 8mm
• 00840019908771: CRT Peek 5 degree x 7mm
• 00840019908764: CRT Peek 5 degree x 6mm
• 00840019908757: CRT Peek 5 degree x 5mm