ProGen PRP Eclipse

GUDID 00850034511474

30mL Platelet Rich Plasma production device.

Bimini Technologies LLC

Haematological concentrate system
Primary Device ID00850034511474
NIH Device Record Key733c4e44-17d5-45ec-8817-d6dfdd63318f
Commercial Distribution StatusIn Commercial Distribution
Brand NameProGen PRP Eclipse
Version Model NumberPROGEN-A30
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
GS100850034511450 [Primary]
GS100850034511474 [Package]
Contains: 00850034511450
Package: Box [3 Units]
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 Date2023-01-12
Device Publish Date2023-01-04

On-Brand Devices [ProGen PRP Eclipse]

0085003451147430mL Platelet Rich Plasma production device.
0085003451122115ML Platelet Rich Plasma production device.

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