PicoMix V

GUDID 08058964724564

Mixing System and Delivery Syringes

G21 SRL

Orthopaedic cement preparation/delivery kit
Primary Device ID08058964724564
NIH Device Record Keyd27f45c9-d86a-4a71-ad8f-520cb558d8f6
Commercial Distribution StatusIn Commercial Distribution
Brand NamePicoMix V
Version Model Number900129
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
GS108058964724564 [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 Date2024-10-18
Device Publish Date2024-10-10

Devices Manufactured by G21 SRL

08058964727855 - PicoMix Gun2024-10-30
08058964724687 - V-Access2024-10-24
08058964725356 - V-Access2024-10-24
08058964725363 - V-Access2024-10-24
08058964725417 - V-Access2024-10-24
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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