GENIUS Blood and Marrow Concentration (BM/C) System G20060

GUDID M263G200600

60mL Disposable Kit

DSM BIOMEDICAL, INC.

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Primary Device ID	M263G200600
NIH Device Record Key	fb0aabec-ad92-47e4-ba56-a10cc90c6244
Commercial Distribution Status	In Commercial Distribution
Brand Name	GENIUS Blood and Marrow Concentration (BM/C) System
Version Model Number	64150-04
Catalog Number	G20060
Company DUNS	131107757
Company Name	DSM BIOMEDICAL, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter
Total Volume	60 Microliter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M263G200600 [Primary]

FDA Product Code

ORG	Platelet And Plasma Separator For Bone Graft Handling

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-04-09
Device Publish Date	2017-10-02

On-Brand Devices [GENIUS Blood and Marrow Concentration (BM/C) System]

M263G200600	60mL Disposable Kit
M263G2003009	Disposable Unit