ZAVATION DILATION TUBE

GUDID 00197157014902

TIGER 2 X-TAB DILATION TUBE #3

Zavation LLC

Lumbar interspinous decompression instrument set, reusable

• Primary Device ID: 00197157014902
• NIH Device Record Key: d703f5a2-369a-49cf-8fe4-e1d0470967ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZAVATION DILATION TUBE
• Version Model Number: 989-2000-3
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197157014902 [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

[00197157014902]

Moist Heat or Steam Sterilization

[00197157014902]

Moist Heat or Steam Sterilization

[00197157014902]

Moist Heat or Steam Sterilization

[00197157014902]

Moist Heat or Steam Sterilization

[00197157014902]

Moist Heat or Steam Sterilization

[00197157014902]

Moist Heat or Steam Sterilization

[00197157014902]

Moist Heat or Steam Sterilization

[00197157014902]

Moist Heat or Steam Sterilization

[00197157014902]

Moist Heat or Steam Sterilization

[00197157014902]

Moist Heat or Steam Sterilization

[00197157014902]

Moist Heat or Steam Sterilization

[00197157014902]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-11
• Device Publish Date: 2025-06-03

Devices Manufactured by Zavation LLC

• 00197157014155 - ZAVATION DRIVER: 2025-06-11 TIGER 2 SHANK DRIVER, LEVER ACTION, 215mm GLOBUS POWEREASE
• 00197157014162 - ZAVATION DRIVER: 2025-06-11 TIGER 2 SHANK DRIVER, DIAL ACTION, 215mm GLOBUS POWEREASE
• 00197157014179 - ZAVATION DRIVER: 2025-06-11 TIGER 2 SHANK DRIVER, LEVER ACTION, 215mm GLOBUS JACOBS
• 00197157014186 - ZAVATION DRIVER: 2025-06-11 TIGER 2 SHANK DRIVER, DIAL ACTION, 215mm GLOBUS JACOBS
• 00197157014193 - ZAVATION DRIVER: 2025-06-11 TIGER 2 SHANK DRIVER, LEVER ACTION, 215mm CANNULATED GLOBUS POWEREASE
• 00197157014209 - ZAVATION DRIVER: 2025-06-11 TIGER 2 SHANK DRIVER, DIAL ACTION, 215mm CANNULATED GLOBUS POWEREASE
• 00197157014216 - ZAVATION DRIVER: 2025-06-11 TIGER 2 SHANK DRIVER, LEVER ACTION, 215mm CANNULATED GLOBUS JACOBS
• 00197157014223 - ZAVATION DRIVER: 2025-06-11 TIGER 2 SHANK DRIVER, DIAL ACTION, 215mm CANNULATED GLOBUS JACOBS