PunchTac DFX0043A

GUDID 00854629006581

4.75 PunchTac Threaded Anchor PEEK, Preleoaded with Two 2mm Fiber Connect (UHMWPE)

DUNAMIS MEDICAL, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID00854629006581
NIH Device Record Key834e79be-9080-4260-a98a-eed789e3396c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePunchTac
Version Model NumberDFX0043A
Catalog NumberDFX0043A
Company DUNS079471560
Company NameDUNAMIS MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone731-217-2533
Emailrajchavan@dunamismedical.com
Phone731-217-2533
Emailrajchavan@dunamismedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100854629006574 [Primary]
GS100854629006581 [Package]
Contains: 00854629006574
Package: box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-22
Device Publish Date2018-09-21

On-Brand Devices [PunchTac]

000854629006535.5mm Anchor Preloaded with Two #2 DFX Force Suture (UHMWPE)
008546290066423.0mm PunchTac Anchor Peek, Preloaded with Two #2 Force Suture (UHMWPE)
108546290066253.0mm PunchTac Knotless Anchor PEEK
008546290066113.0mm PunchTac Anchor Peek, Preloaded with Two #2 Force Suture (UHMWPE)
108546290065953.0mm PunchTac Knotless Anchor Peek
008546290065814.75 PunchTac Threaded Anchor PEEK, Preleoaded with Two 2mm Fiber Connect (UHMWPE)
00854629006550DFX0042A
008546290065294.5mm Anchor PEEK Preloaded with One #2 DFX Force Suture ( UHMWPE)
008546290065123.0mm Anchor PEEK Preloaded with One #2 DFX Force Suture (UHMWPE)
008546290065365.5mm Anchor Preloaded with Two #2 DFX Force Suture (UHMWPE)

Trademark Results [PunchTac]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PUNCHTAC
PUNCHTAC
87236514 5227633 Live/Registered
Dunamis, LLC
2016-11-14

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