GENESIS PRP 30mL Concentrating System - A sterile, single use, polyester gel media - Bimini Technologies LLC

Duns Number:076649467

Device Description: A sterile, single use, polyester gel media containing, vacuum evacuated tube that is inten

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

GENESIS PRP 30mL Concentrating System

Version/Model Number

HEALPRP30

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

BK170136

Product Code Details

Product Code

ORG

Product Code Name

Platelet And Plasma Separator For Bone Graft Handling

Device Record Status

Public Device Record Key

426ee011-3866-4612-91a1-ca1a92bbb3f9

Public Version Date

February 25, 2022

Public Version Number

1

DI Record Publish Date

February 17, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIMINI TECHNOLOGIES LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 17