PunchTac 6.5 mm Anchor PEEK DFX0037A

GUDID 10854629006298

6.5 mm PunchTac™ Threaded Anchor PEEK Preloaded with Two #2 DFX Force Suture and One 1.5mm DFX Tensile Tape (UHMWPE) Sterile | Single Use

DUNAMIS MEDICAL, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 10854629006298
• NIH Device Record Key: b3e975b5-fc5f-4ca9-a03e-bd2a3beac651
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PunchTac 6.5 mm Anchor PEEK
• Version Model Number: DFX0037A
• Catalog Number: DFX0037A
• 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	00854629006291 [Primary]
GS1	10854629006298 [Package]; Contains: 00854629006291; 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

Devices Manufactured by DUNAMIS MEDICAL, LLC

• 00850052601249 - Orca™ Implantation Kit: 2024-06-28 Orca™ Implantation Kit
• 00850052601072 - Hallux Guide: 2024-06-18 Hallux Guide
• 00850052601089 - CMC Spacer: 2024-06-18 CMC Spacer
• 00850052601096 - CMC Guide: 2024-06-18 CMC Guide
• 00850052601157 - Threaded Driver: 2024-06-18 Threaded Driver
• 00850052601232 - Micro Constrictor® Implantation Kit: 2024-06-18 Micro Constrictor® Implantation Kit
• 00850052601225 - Orca Xtreme ™ Kit Knotless Button: 2024-03-22 Orca Xtreme™ Kit Knotless Button
• 00850052601188 - Force DFX Suture-Xtreme™: 2024-02-08 Force DFX Suture-Xtreme™