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 ID10854629006298
NIH Device Record Keyb3e975b5-fc5f-4ca9-a03e-bd2a3beac651
Commercial Distribution StatusIn Commercial Distribution
Brand NamePunchTac 6.5 mm Anchor PEEK
Version Model NumberDFX0037A
Catalog NumberDFX0037A
Company DUNS079471560
Company NameDUNAMIS MEDICAL, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100854629006291 [Primary]
GS110854629006298 [Package]
Contains: 00854629006291
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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-04-12

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00850052601225 - Orca Xtreme ™ Kit Knotless Button2024-03-22 Orca Xtreme™ Kit Knotless Button
00850052601188 - Force DFX Suture-Xtreme™2024-02-08 Force DFX Suture-Xtreme™
00850052601195 - Fixation Button-Oblong2024-02-08 Fixation Button-Oblong

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