TensionTac DFX0045R

GUDID 00854629006987

TensionTac 3.5 Knotless Anchor PEEK

DUNAMIS MEDICAL, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00854629006987
• NIH Device Record Key: 2d2d64d6-7ad5-4b32-9535-45fe81515494
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TensionTac
• Version Model Number: DFX0045R
• Catalog Number: DFX0045R
• Company DUNS: 079471560
• Company Name: DUNAMIS MEDICAL, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00854629006987 [Primary]

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

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: 2023-08-21
• Device Publish Date: 2023-08-11

On-Brand Devices [TensionTac]

• 10854629006779: TensionTac 3.0 Knotless Anchor PEEK
• 00854629006987: TensionTac 3.5 Knotless Anchor PEEK