Spectrum GV

GUDID 00855195006616

Spectrum GV Bone Cement -1x40

OSTEOREMEDIES, LLC

Orthopaedic cement spacer
Primary Device ID00855195006616
NIH Device Record Key1f4af750-4cb9-41c3-83fb-cf5dc3b9c6f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpectrum GV
Version Model NumberSPECTRUM40
Company DUNS079596704
Company NameOSTEOREMEDIES, 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 Producttrue
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
GS100855195006616 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBBBone Cement, Antibiotic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-21
Device Publish Date2018-11-20

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