DirectCell Autograft and Marrow Harvesting System AMS-MC-RAN-8C

GUDID 00812593021566

Contains: (1) MC-RAN-8C, Marrow Cellution Bone Marrow Biopsy Kit

Biogennix, LLC

Bone marrow biopsy procedure kit

• Primary Device ID: 00812593021566
• NIH Device Record Key: f205722b-0f16-43b7-af2d-52343bc83989
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DirectCell Autograft and Marrow Harvesting System
• Version Model Number: AMS-MC-RAN-8C
• Catalog Number: AMS-MC-RAN-8C
• Company DUNS: 832270370
• Company Name: Biogennix, LLC
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812593021566 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190177

FDA Product Code

• KNW: Instrument, Biopsy

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-22
• Device Publish Date: 2021-03-12

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• 00812593021955 - Summit Moldable: 2025-03-03 Summit Moldable 5cc
• 00812593021962 - Summit Moldable: 2025-03-03 Summit Moldable 10cc
• 00812593021979 - Summit Strip: 2025-03-03 Summit Strip 2.5cm x 5xm x 0.8cm
• 00812593021986 - Summit Strip: 2025-03-03 Summit Strip 2.5cm x 10cm x 0.8cm
• 00812593021924 - InteliPowder: 2025-02-19 InteliPowder Surgical Matrix 5mL