TensionTac DFX0045R

GUDID 00854629006987

TensionTac 3.5 Knotless Anchor PEEK

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 ID00854629006987
NIH Device Record Key2d2d64d6-7ad5-4b32-9535-45fe81515494
Commercial Distribution StatusIn Commercial Distribution
Brand NameTensionTac
Version Model NumberDFX0045R
Catalog NumberDFX0045R
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100854629006987 [Primary]

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 Date2023-08-21
Device Publish Date2023-08-11

On-Brand Devices [TensionTac]

10854629006779TensionTac 3.0 Knotless Anchor PEEK
00854629006987TensionTac 3.5 Knotless Anchor PEEK

Trademark Results [TensionTac]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TENSIONTAC
TENSIONTAC
88793927 not registered Live/Pending
Dunamis Medical, LLC
2020-02-12

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