Identity
- Trade Name
- BMAN Solid Diamond Needle Kit - Two Pack FDA UDI
- Generic Name
- Bone marrow biopsy procedure kit FDA UDI
- Model / Reference
- SR07-1103 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810131880972 FDA UDI
- 510(k) Number
- K240664 FDA UDI
- FDA Product Code
- PDQ FDA UDI
- GMDN Term
- Bone marrow biopsy procedure kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1820 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
BMAN Solid Diamond Needle Kit - Two Pack by Surgentec Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K240664 also covers:
- BMAC Bevel Needle — SURGENTEC LLC
- BMAC Bevel Needle - Two Pack — SURGENTEC LLC
- BMAC Bevel Needle Assembly — SURGENTEC LLC
- BMAC Bevel Needle Kit — SURGENTEC LLC
- BMAC Bevel Needle Kit - Two Pack — SURGENTEC LLC
- BMAC Bevel Needle Pouched — SURGENTEC LLC
- BMAC Diamond Needle — SURGENTEC LLC
- BMAC Diamond Needle - Two Pack — SURGENTEC LLC
- BMAC Diamond Needle Assembly — SURGENTEC LLC
- BMAC Diamond Needle Kit — SURGENTEC LLC
- BMAC Diamond Needle Kit - Two Pack Copy — SURGENTEC LLC
- BMAC Diamond Needle Pouched — SURGENTEC LLC
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
- Surgentec Llc
Sources (1)
- FDA UDI 4af1c750-8e12-4f76-87d7-74c92551963d 33 fields · synced Jun 8, 2026