Identity
- Trade Name
- Bone Access Kit FDA UDI
- Generic Name
- Bone marrow biopsy procedure kit FDA UDI
- Device Name
- Convenience kit no Lidocaine FDA UDI
- Model / Reference
- 3404 FDA UDI
- Description
- Convenience kit no Lidocaine FDA UDI
Identifiers
- Catalog Number
- 3404 FDA UDI
- Primary DI / UDI-DI
- B87534040 FDA UDI
- FDA Product Code
- PXO FDA UDI
- GMDN Term
- Bone marrow biopsy procedure kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Combination Product
Yes
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
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Bone marrow biopsy procedure kit
Bone Access Kit by Custom Interventional Pain Management — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Custom Interventional Pain Management
Sources (1)
- FDA UDI 6f0271ac-a07f-4367-b0d7-90cbb669a0e9 34 fields · synced May 30, 2026