PunchTac 5.5mm Anchor PEEK DFX0035A

GUDID 00854629006260

5.5mm PunchTac™ Threaded Anchor PEEK Preloaded with Two 2mm DFX Tensile Tape (UHMWPE) Sterile | Single Use

DUNAMIS MEDICAL, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00854629006260
• NIH Device Record Key: 8d9d2c79-2dac-41a0-a6b5-9b898282c90d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PunchTac 5.5mm Anchor PEEK
• Version Model Number: DFX0035A
• Catalog Number: DFX0035A
• 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

Customer Support Contacts

• Phone: 877.454.2186
• Email: info@dunamismedical.com
• Phone: 877.454.2186
• Email: info@dunamismedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854629006253 [Primary]
GS1	00854629006260 [Package]; Contains: 00854629006253; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160996

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-12

On-Brand Devices [PunchTac 5.5mm Anchor PEEK]

• 00854629006260: 5.5mm PunchTac™ Threaded Anchor PEEK Preloaded with Two 2mm DFX Tensile Tape (UHMWPE) S
• 00854629006192: Suture Anchor 5.5 PEEK Sterile Double Loaded Sutures #2 White/Blue Cobraid #2 White/Black Cobr