PunchTac 5.5mm Anchor PEEK DFX0031A

GUDID 00854629006192

Suture Anchor 5.5 PEEK Sterile Double Loaded Sutures #2 White/Blue Cobraid #2 White/Black Cobraid

DUNAMIS MEDICAL, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID00854629006192
NIH Device Record Key206d6013-8e50-44cf-a844-e63a83b33b00
Commercial Distribution StatusIn Commercial Distribution
Brand NamePunchTac 5.5mm Anchor PEEK
Version Model NumberDFX0031A
Catalog NumberDFX0031A
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
GS100854629006185 [Primary]
GS100854629006192 [Package]
Contains: 00854629006185
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

On-Brand Devices [PunchTac 5.5mm Anchor PEEK]

008546290062605.5mm PunchTac™ Threaded Anchor PEEK Preloaded with Two 2mm DFX Tensile Tape (UHMWPE) S
00854629006192Suture Anchor 5.5 PEEK Sterile Double Loaded Sutures #2 White/Blue Cobraid #2 White/Black Cobr

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