PunchTac DFX0042A
GUDID 00854629006550
DUNAMIS MEDICAL, LLC
Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile| Primary Device ID | 00854629006550 |
| NIH Device Record Key | dd36f5d3-bcb4-4e71-89b2-0911e4bf301a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PunchTac |
| Version Model Number | DFX0042A |
| Catalog Number | DFX0042A |
| Company DUNS | 079471560 |
| Company Name | DUNAMIS MEDICAL, LLC |
| Device Count | 1 |
| DM Exempt | false |
| 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 | 7312172533 |
| rajchavan@dunamismedical.com | |
| Phone | 7312172533 |
| rajchavan@dunamismedical.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854629006550 [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 | 1 |
| Public Version Date | 2018-08-06 |
| Device Publish Date | 2018-07-05 |
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) |
Trademark Results [PunchTac]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PUNCHTAC 87236514 5227633 Live/Registered |
Dunamis, LLC 2016-11-14 |
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