ZAVATION PROBE

GUDID 00197157013325

TIGER 2 BALL TIP PROBE, Ti

Zavation LLC

Bone tap, reusable

• Primary Device ID: 00197157013325
• NIH Device Record Key: b58b6b32-c629-490e-ac24-467404334492
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZAVATION PROBE
• Version Model Number: 989-1001
• 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	00197157013325 [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

[00197157013325]

Moist Heat or Steam Sterilization

[00197157013325]

Moist Heat or Steam Sterilization

[00197157013325]

Moist Heat or Steam Sterilization

[00197157013325]

Moist Heat or Steam Sterilization

[00197157013325]

Moist Heat or Steam Sterilization

[00197157013325]

Moist Heat or Steam Sterilization

[00197157013325]

Moist Heat or Steam Sterilization

[00197157013325]

Moist Heat or Steam Sterilization

[00197157013325]

Moist Heat or Steam Sterilization

[00197157013325]

Moist Heat or Steam Sterilization

[00197157013325]

Moist Heat or Steam Sterilization

[00197157013325]

Moist Heat or Steam Sterilization

[00197157013325]

Moist Heat or Steam Sterilization

[00197157013325]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-10
• Device Publish Date: 2025-06-02

On-Brand Devices [ZAVATION PROBE]

• 00197157013325: TIGER 2 BALL TIP PROBE, Ti
• 00197157013318: TIGER 2 BALL TIP PROBE, SS