Identity
- Trade Name
- Tantalum Bead Set FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- Tantalum bead implants are used as radio-opaque markers and may be implanted into bone or soft tissue FDA UDI
- Model / Reference
- 2 FDA UDI
- Description
- Tantalum bead implants are used as radio-opaque markers and may be implanted into bone or soft tissue FDA UDI
Identifiers
- Catalog Number
- P005603 FDA UDI
- Primary DI / UDI-DI
- 00628451892014 FDA UDI
- FDA Product Code
- NEU FDA UDI
- GMDN Term
- Radiological image marker, implantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
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: Radiological image marker, implantable
Tantalum Bead Set by Halifax Biomedical Incorporated — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Halifax Biomedical Incorporated
Sources (1)
- FDA UDI b4ecc89d-c2c4-4c84-a77d-0dec7ced06a4 35 fields · synced May 30, 2026