ZAVATION TRAY

GUDID 00197157015237

TIGER 2, TRAY, ROBOTIC NAVIGATION INSTRUMENTS

Zavation LLC

Instrument tray, reusable

• Primary Device ID: 00197157015237
• NIH Device Record Key: 4eaa8863-d524-4194-b675-7532abd664e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZAVATION TRAY
• Version Model Number: 14G00754
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197157015237 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243908

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00197157015237]

Moist Heat or Steam Sterilization

[00197157015237]

Moist Heat or Steam Sterilization

[00197157015237]

Moist Heat or Steam Sterilization

[00197157015237]

Moist Heat or Steam Sterilization

[00197157015237]

Moist Heat or Steam Sterilization

[00197157015237]

Moist Heat or Steam Sterilization

[00197157015237]

Moist Heat or Steam Sterilization

[00197157015237]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-12
• Device Publish Date: 2025-06-04

On-Brand Devices [ZAVATION TRAY]

• 00197157015305: TIGER 2, TRAY, DEFORMITY RODS
• 00197157015299: TIGER 2, TRAY, SACROILLIAC
• 00197157015268: TIGER 2, CADDY, ROD CONNECTOR - TOP LOADING
• 00197157015251: TIGER 2, TRAY, ROD CONNECTORS - INSTRUMENTS
• 00197157015244: TIGER 2, TRAY, ROD CONNECTORS - IMPLANTS
• 00197157015237: TIGER 2, TRAY, ROBOTIC NAVIGATION INSTRUMENTS
• 00197157015220: TIGER 2, TRAY, NAVIGATED INSTRUMENTS
• 00197157015121: TIGER 2, TRAY, SCREW SHANK CADDIES
• 00197157015107: TIGER 2, TRAY, INNER LID
• 00197157015084: TIGER 2, TRAY, ROD REDUCTION AND LOCKING