ShurFit ACIF Titanium CRT005

GUDID 00815362022122

ACIF Cage 5 degree x 5mm

PRECISION SPINE, INC.

Metallic spinal fusion cage, non-sterile

• Primary Device ID: 00815362022122
• NIH Device Record Key: 06be1b84-da4a-42b8-9ac0-4a0cd62d5bd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ShurFit ACIF Titanium
• Version Model Number: CRT005
• Catalog Number: CRT005
• 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	00815362022122 [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

[00815362022122]

Moist Heat or Steam Sterilization

[00815362022122]

Moist Heat or Steam Sterilization

[00815362022122]

Moist Heat or Steam Sterilization

[00815362022122]

Moist Heat or Steam Sterilization

[00815362022122]

Moist Heat or Steam Sterilization

[00815362022122]

Moist Heat or Steam Sterilization

[00815362022122]

Moist Heat or Steam Sterilization

[00815362022122]

Moist Heat or Steam Sterilization

[00815362022122]

Moist Heat or Steam Sterilization

[00815362022122]

Moist Heat or Steam Sterilization

[00815362022122]

Moist Heat or Steam Sterilization

[00815362022122]

Moist Heat or Steam Sterilization

[00815362022122]

Moist Heat or Steam Sterilization

[00815362022122]

Moist Heat or Steam Sterilization

[00815362022122]

Moist Heat or Steam Sterilization

[00815362022122]

Moist Heat or Steam Sterilization

[00815362022122]

Moist Heat or Steam Sterilization

[00815362022122]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-05
• Device Publish Date: 2019-03-28

On-Brand Devices [ShurFit ACIF Titanium ]

• 00840019929271: ACIF Cage 5 degree x 10mm
• 00840019929264: ACIF Cage 5 degree x 9mm
• 00840019929240: ACIF Cage 5 degree x 7mm
• 00840019929257: ACIF Cage 5 degree x 8mm
• 00840019929233: ACIF Cage 5 degree x 6mm
• 00815362022122: ACIF Cage 5 degree x 5mm