Gold Rush PRP

GUDID 00850034511979

30ML Platelet Rich Plasma production device.

Bimini Technologies LLC

Haematological concentrate system
Primary Device ID00850034511979
NIH Device Record Key74d5ff47-ff98-4200-972a-95123d12652a
Commercial Distribution StatusIn Commercial Distribution
Brand NameGold Rush PRP
Version Model Number530102-1
Company DUNS076649467
Company NameBimini Technologies LLC
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 Identifiers

Device Issuing AgencyDevice ID
GS100850034511962 [Primary]
GS100850034511979 [Package]
Contains: 00850034511962
Package: Box [3 Units]
Discontinued: 2024-03-28
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ORGPlatelet And Plasma Separator For Bone Graft Handling

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-05
Device Publish Date2024-03-28

On-Brand Devices [Gold Rush PRP]

0085003451197930ML Platelet Rich Plasma production device.
0085003451195515ML Platelet Rich Plasma production device.

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