G3 40 Radiopaque Bone Cement

GUDID 08058964720047

Radiopaque Bone Cement

G21 SRL

Orthopaedic cement, non-medicated
Primary Device ID08058964720047
NIH Device Record Key7f24be8d-26c2-4b53-b382-d152dad8ab68
Commercial Distribution StatusIn Commercial Distribution
Brand NameG3 40 Radiopaque Bone Cement
Version Model Number800004
Company DUNS431529195
Company NameG21 SRL
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 Datefalse
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
GS108058964720047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LODBone Cement

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-09
Device Publish Date2020-04-01

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