TightFix Interference Screw 10mm PEEK DFX0003T

GUDID 00854629006123

DUNAMIS MEDICAL, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID00854629006123
NIH Device Record Keyb2d1d776-baed-4996-9ab4-5de1a6845c61
Commercial Distribution StatusIn Commercial Distribution
Brand NameTightFix Interference Screw 10mm PEEK
Version Model NumberDFX0003T
Catalog NumberDFX0003T
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
GS100854629006123 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-04-11

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