Arthrex Bone Cement Closed Mixing Bowl

GUDID 08058964729057

G21 SRL

Orthopaedic cement preparation/delivery kit
Primary Device ID08058964729057
NIH Device Record Key692bd72a-a847-4447-ae07-94047abcb6cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameArthrex Bone Cement Closed Mixing Bowl
Version Model NumberAS-901-2
Company DUNS431529195
Company NameG21 SRL
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 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
GS108058964729057 [Primary]

FDA Product Code

JDZMixer, Cement, For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-22
Device Publish Date2024-10-14

On-Brand Devices [Arthrex Bone Cement Closed Mixing Bowl ]

08058964729057AS-901-2
08058964728753AR-901-2

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