PunchTac 4.5mm Anchor DFX0030A

GUDID 10854629006175

Suture Anchor 4.5 PEEK Sterile Single Loaded Suture #2 White/Black Cobraid

DUNAMIS MEDICAL, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID10854629006175
NIH Device Record Keyf075de5a-3b7d-470d-8a3f-d66f73600f49
Commercial Distribution StatusIn Commercial Distribution
Brand NamePunchTac 4.5mm Anchor
Version Model NumberDFX0030A
Catalog NumberDFX0030A
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
GS100854629006178 [Primary]
GS110854629006175 [Package]
Contains: 00854629006178
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 Date2017-04-11

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