OSSEOFIX + 21302

GUDID 03760177047044

TEKNIMED

Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit
Primary Device ID03760177047044
NIH Device Record Keye8535be7-e5bc-4598-9e1f-6c2a5637bb22
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSSEOFIX +
Version Model NumberPRECISION PACK
Catalog Number21302
Company DUNS764746723
Company NameTEKNIMED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
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
GS103760177047044 [Primary]
GS103760177047044 [Primary]
GS103760177047044 [Primary]
GS103760177047044 [Primary]
GS103760177047044 [Primary]
GS103760177047044 [Primary]
GS103760177047044 [Primary]
GS103760177047044 [Primary]
GS103760177047044 [Primary]
GS103760177047044 [Primary]
GS103760177047044 [Primary]
GS103760177047044 [Primary]
GS103760177047044 [Primary]
GS103760177047044 [Primary]

FDA Product Code

OARInjector, Vertebroplasty (Does Not Contain Cement)
OARInjector, Vertebroplasty (Does Not Contain Cement)
OARInjector, Vertebroplasty (Does Not Contain Cement)
OARInjector, Vertebroplasty (Does Not Contain Cement)
OARInjector, Vertebroplasty (Does Not Contain Cement)
OARInjector, Vertebroplasty (Does Not Contain Cement)
OARInjector, Vertebroplasty (Does Not Contain Cement)
OARInjector, Vertebroplasty (Does Not Contain Cement)
OARInjector, Vertebroplasty (Does Not Contain Cement)
OARInjector, Vertebroplasty (Does Not Contain Cement)
OARInjector, Vertebroplasty (Does Not Contain Cement)
OARInjector, Vertebroplasty (Does Not Contain Cement)
OARInjector, Vertebroplasty (Does Not Contain Cement)
OARInjector, Vertebroplasty (Does Not Contain Cement)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-15
Device Publish Date2020-10-07

On-Brand Devices [OSSEOFIX +]

0376017704633721390
03760177047044PRECISION PACK

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