PunchTac DFX0028R

GUDID 00854629006512

3.0mm Anchor PEEK Preloaded with One #2 DFX Force Suture (UHMWPE)

DUNAMIS MEDICAL, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00854629006512
• NIH Device Record Key: 90981139-d547-4fd3-a5c9-75c5b16164ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PunchTac
• Version Model Number: DFX0028R
• Catalog Number: DFX0028R
• Company DUNS: 079471560
• Company Name: DUNAMIS MEDICAL, LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 334-371-6280
• Email: dr.Raj76@gmail.com
• Phone: 334-371-6280
• Email: dr.Raj76@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854629006512 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-17

On-Brand Devices [PunchTac]

• 00085462900653: 5.5mm Anchor Preloaded with Two #2 DFX Force Suture (UHMWPE)
• 00854629006642: 3.0mm PunchTac Anchor Peek, Preloaded with Two #2 Force Suture (UHMWPE)
• 10854629006625: 3.0mm PunchTac Knotless Anchor PEEK
• 00854629006611: 3.0mm PunchTac Anchor Peek, Preloaded with Two #2 Force Suture (UHMWPE)
• 10854629006595: 3.0mm PunchTac Knotless Anchor Peek
• 00854629006581: 4.75 PunchTac Threaded Anchor PEEK, Preleoaded with Two 2mm Fiber Connect (UHMWPE)
• 00854629006550: DFX0042A
• 00854629006529: 4.5mm Anchor PEEK Preloaded with One #2 DFX Force Suture ( UHMWPE)
• 00854629006512: 3.0mm Anchor PEEK Preloaded with One #2 DFX Force Suture (UHMWPE)
• 00854629006536: 5.5mm Anchor Preloaded with Two #2 DFX Force Suture (UHMWPE)