Identity
- Trade Name
- DirectCell Autograft and Marrow Harvesting System FDA UDI
- Generic Name
- Bone marrow biopsy procedure kit FDA UDI
- Device Name
- Contains: (1) MC-RAN-8C, Marrow Cellution Bone Marrow Biopsy Kit FDA UDI
- Model / Reference
- AMS-MC-RAN-8C FDA UDI
- Description
- Contains: (1) MC-RAN-8C, Marrow Cellution Bone Marrow Biopsy Kit FDA UDI
Identifiers
- Catalog Number
- AMS-MC-RAN-8C FDA UDI
- Primary DI / UDI-DI
- 00812593021566 FDA UDI
- 510(k) Number
- K190177 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Bone marrow biopsy procedure kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Bone marrow biopsy procedure kit
DirectCell Autograft and Marrow Harvesting System by Biogennix, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K190177 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biogennix, LLC
Sources (1)
- FDA UDI f205722b-0f16-43b7-af2d-52343bc83989 35 fields · synced Jun 8, 2026