Tornado™

GUDID 10840642168709

Bioactive Bone Matrix, 5 cc Moldable Strip

Spine Wave, Inc.

Bone matrix implant, animal-derived, bioabsorbable

• Primary Device ID: 10840642168709
• NIH Device Record Key: 84835b23-3bda-4b02-a18b-c3b4a74a8282
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tornado™
• Version Model Number: 11-5805
• Company DUNS: 067789763
• Company Name: Spine Wave, Inc.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642168709 [Primary]

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-19
• Device Publish Date: 2021-10-11

On-Brand Devices [Tornado™]

• 10840642159653: Bioactive Bone Matrix, 14 cc Moldable Puck
• 10840642159646: Bioactive Bone Matrix, 7 cc Moldable Puck
• 10840642159639: Bioactive Bone Matrix, 40 cc Moldable Strip
• 10840642159622: Bioactive Bone Matrix, 20 cc Moldable Strip
• 10840642159615: Bioactive Bone Matrix, 10 cc Moldable Strip
• 10840642168709: Bioactive Bone Matrix, 5 cc Moldable Strip