Arthrex Bone Cement MV w/G

GUDID 08058964728746

G21 SRL

Orthopaedic cement, antimicrobial
Primary Device ID08058964728746
NIH Device Record Key7fb7484a-740e-4bec-b96a-14665ae4d612
Commercial Distribution StatusIn Commercial Distribution
Brand NameArthrex Bone Cement MV w/G
Version Model NumberAR-901-MVG
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 Producttrue
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
GS108058964728746 [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 Date2024-09-24
Device Publish Date2024-09-16

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08058964726797 - SpaceFlex Shoulder Instrument Kit2024-10-24
08058964723758 - Disp. Mixing Bowl-O2024-10-22 OPEN MIXING SYSTEM FOR BONE CEMENT PREPARATION
08058964724427 - KeyFix Bone Drill2024-10-22

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