Genius Concentration System G00001

GUDID M263G000010

Centrifuge

DSM BIOMEDICAL, INC.

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• Primary Device ID: M263G000010
• NIH Device Record Key: a89d1441-8107-4a08-be81-a8b4ee28884e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genius Concentration System
• Version Model Number: 64002-09
• Catalog Number: G00001
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M263G000010 [Direct Marking]
HIBCC	M263G00001K0 [Primary]

FDA Product Code

• ORG: Platelet And Plasma Separator For Bone Graft Handling

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-12-22

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