5.5mm PunchTac™ Threaded Anchor PEEK DFX0040A

GUDID 00854629006321

5.5mm PunchTac™ Threaded Anchor PEEK Preloaded with Two 2mm Fiber Connect (UHMWPE)

DUNAMIS MEDICAL, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID00854629006321
NIH Device Record Keya82ac6f8-c849-42eb-934d-8588c81423b5
Commercial Distribution StatusIn Commercial Distribution
Brand Name5.5mm PunchTac™ Threaded Anchor PEEK
Version Model NumberDFX0040A
Catalog NumberDFX0040A
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
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100854629006321 [Primary]

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 Date2023-08-25
Device Publish Date2023-08-17

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