GENIUS Blood and Marrow Concentration (BM/C) System - 60mL Disposable Kit - DSM BIOMEDICAL, INC.

Duns Number:131107757

Device Description: 60mL Disposable Kit

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More Product Details

Catalog Number

G20060

Brand Name

GENIUS Blood and Marrow Concentration (BM/C) System

Version/Model Number

64150-04

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code Details

Product Code

ORG

Product Code Name

Platelet And Plasma Separator For Bone Graft Handling

Device Record Status

Public Device Record Key

fb0aabec-ad92-47e4-ba56-a10cc90c6244

Public Version Date

July 23, 2020

Public Version Number

5

DI Record Publish Date

October 02, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DSM BIOMEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 132
U Unclassified 5