Osteo-site VCF Kit, Vertefix MV Cement

GUDID 00815212026782

Izi Medical Products, LLC

Orthopaedic cement, non-antimicrobial
Primary Device ID00815212026782
NIH Device Record Key281a6047-212b-44cb-bfc7-e8bfeeb1618d
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteo-site VCF Kit, Vertefix MV Cement
Version Model NumberG80009
Company DUNS933506164
Company NameIzi Medical Products, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815212026782 [Primary]

FDA Product Code

NDNCement, Bone, Vertebroplasty

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-26
Device Publish Date2024-02-16

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