Identity
- Trade Name
- Bone Marrow Biopsy FDA UDI
- Generic Name
- Bone marrow biopsy needle, single-use FDA UDI
- Device Name
- Custom Bone Marrow Biopsy Tray FDA UDI
- Model / Reference
- CB0429TLA FDA UDI
- Description
- Custom Bone Marrow Biopsy Tray FDA UDI
Identifiers
- Catalog Number
- CB0429TLA FDA UDI
- Primary DI / UDI-DI
- 00886333225569 FDA UDI
- FDA Product Code
- OJT FDA UDI
- GMDN Term
- Bone marrow biopsy needle, single-use 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
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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 needle, single-use
Bone Marrow Biopsy by Argon Medical Devices, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- MED-L — Medax Unipersonale Srl · Class II
- 0BIE1410/075 — Biomedical S.r.l. · Class IIa
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
- Argon Medical Devices, Inc.
Sources (1)
- FDA UDI e5df4c88-2ddb-4b63-8e1a-e03588937eff 35 fields · synced Jun 9, 2026