GENIUS Platelet Rich Plasma (PRP) System G10030

GUDID M263G1003008

Disposable Kit

DSM BIOMEDICAL, INC.

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Primary Device IDM263G1003008
NIH Device Record Key9e81f895-ab85-44fa-a1f7-ed1ed262a727
Commercial Distribution StatusIn Commercial Distribution
Brand NameGENIUS Platelet Rich Plasma (PRP) System
Version Model Number64000-05
Catalog NumberG10030
Company DUNS131107757
Company NameDSM BIOMEDICAL, INC.
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM263G1003008 [Primary]

FDA Product Code

ORGPlatelet And Plasma Separator For Bone Graft Handling

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-09
Device Publish Date2016-10-31

On-Brand Devices [GENIUS Platelet Rich Plasma (PRP) System]

M263G100600Disposable Kit
M263G1003008Disposable Kit
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