Zavation CUSTOM TAP, CANNULATED

GUDID 00197157029371

CUSTOM TAP, CANNULATED 9.5mm Short

Zavation LLC

Bone tap, reusable

• Primary Device ID: 00197157029371
• NIH Device Record Key: 68af8975-ef9f-40c5-aa18-49e5165d5812
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zavation CUSTOM TAP, CANNULATED
• Version Model Number: ZAV-1365-95S
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197157029371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222614

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[00197157029371]

Moist Heat or Steam Sterilization

[00197157029371]

Moist Heat or Steam Sterilization

[00197157029371]

Moist Heat or Steam Sterilization

[00197157029371]

Moist Heat or Steam Sterilization

[00197157029371]

Moist Heat or Steam Sterilization

[00197157029371]

Moist Heat or Steam Sterilization

[00197157029371]

Moist Heat or Steam Sterilization

[00197157029371]

Moist Heat or Steam Sterilization

[00197157029371]

Moist Heat or Steam Sterilization

[00197157029371]

Moist Heat or Steam Sterilization

[00197157029371]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-12
• Device Publish Date: 2024-09-04

On-Brand Devices [Zavation CUSTOM TAP, CANNULATED]

• 00197157029432: CUSTOM TAP, CANNULATED 9.5mm Long
• 00197157029425: CUSTOM TAP, CANNULATED 8.5mm Long
• 00197157029418: CUSTOM TAP, CANNULATED 7.5mm Long
• 00197157029401: CUSTOM TAP, CANNULATED 6.5mm Long
• 00197157029395: CUSTOM TAP, CANNULATED 5.5mm Long
• 00197157029388: CUSTOM TAP, CANNULATED 4.5mm Long
• 00197157029371: CUSTOM TAP, CANNULATED 9.5mm Short
• 00197157029364: CUSTOM TAP, CANNULATED 8.5mm Short
• 00197157029357: CUSTOM TAP, CANNULATED 7.5mm Short
• 00197157029340: CUSTOM TAP, CANNULATED 6.5mm Short
• 00197157029333: CUSTOM TAP, CANNULATED 5.5mm Short
• 00197157029326: CUSTOM TAP, CANNULATED 4.5mm Short