DirectCell Autograft and Marrow Harvesting System

Basic Information

• Brand Name: DirectCell Autograft and Marrow Harvesting System
• Primary DI: 00812593021566
• Version / Model: AMS-MC-RAN-8C
• Catalog Number: AMS-MC-RAN-8C
• Company Name: Biogennix, LLC
• Labeler DUNS: 832270370
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-12
• Public Version: 1
• Public Version Date: 2021-03-22
• Public Version Status: New
• Public Device Record Key: f205722b-0f16-43b7-af2d-52343bc83989

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNW	Instrument, Biopsy	Gastroenterology, Urology	876.1075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16833	Bone marrow biopsy procedure kit	A packaged collection of sterile equipment that includes a disposable biopsy needle and other supplies used to perform a histologic specimen aspiration during a bone marrow biopsy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812593021566	GS1

Premarket Submissions

Submission Number	Supplement Number
K190177	000