PEAK® Platelet Rich Plasma System 278010

GUDID 00812337026239

Centrifuge for preparation of platelet rich plasma

DSM BIOMEDICAL, INC.

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• Primary Device ID: 00812337026239
• NIH Device Record Key: 84924fad-f514-4e49-8c5a-53398afb5e15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEAK® Platelet Rich Plasma System
• Version Model Number: 64002-01
• Catalog Number: 278010
• 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
GS1	00812337026215 [Primary]
GS1	00812337026239 [Direct Marking]

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: 3
• Public Version Date: 2019-02-13
• Device Publish Date: 2016-08-17

On-Brand Devices [PEAK® Platelet Rich Plasma System]

• 00812337026239: Centrifuge for preparation of platelet rich plasma
• 00812337026017: Disposable Unit
• 00812337026031: Disposable Unit