Zavation LABYRINTH PLIF SIZER

GUDID 00197157026745

LABYRINTH PLIF SIZER 13MM

Zavation LLC

Surgical implant/trial-implant/sizer holder, reusable

• Primary Device ID: 00197157026745
• NIH Device Record Key: 4c21596e-a734-4d57-aa4e-276bc0cec170
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zavation LABYRINTH PLIF SIZER
• Version Model Number: ZAV-1359-13
• Company DUNS: 069472800
• Company Name: Zavation LLC
• 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: false
• Lot Batch: true
• 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

Customer Support Contacts

• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197157026745 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202305

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[00197157026745]

Moist Heat or Steam Sterilization

[00197157026745]

Moist Heat or Steam Sterilization

[00197157026745]

Moist Heat or Steam Sterilization

[00197157026745]

Moist Heat or Steam Sterilization

[00197157026745]

Moist Heat or Steam Sterilization

[00197157026745]

Moist Heat or Steam Sterilization

[00197157026745]

Moist Heat or Steam Sterilization

[00197157026745]

Moist Heat or Steam Sterilization

[00197157026745]

Moist Heat or Steam Sterilization

[00197157026745]

Moist Heat or Steam Sterilization

[00197157026745]

Moist Heat or Steam Sterilization

[00197157026745]

Moist Heat or Steam Sterilization

[00197157026745]

Moist Heat or Steam Sterilization

[00197157026745]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-16
• Device Publish Date: 2024-09-06

On-Brand Devices [Zavation LABYRINTH PLIF SIZER]

• 00197157026776: LABYRINTH PLIF SIZER 16MM
• 00197157026769: LABYRINTH PLIF SIZER 15MM
• 00197157026752: LABYRINTH PLIF SIZER 14MM
• 00197157026745: LABYRINTH PLIF SIZER 13MM
• 00197157026738: LABYRINTH PLIF SIZER 12MM