Identity
- Trade Name
- Theragenics FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Model / Reference
- 0811-1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813787021836 FDA UDI
- 510(k) Number
- K071550 FDA UDI
- FDA Product Code
- KXK FDA UDI
- GMDN Term
- Radiological image marker, implantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5730 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Radiological image marker, implantable
Theragenics by Theragenics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K071550 also covers:
- FN NEEDLES — Cp Medical
- FN NEEDLES — Cp Medical
- FN NEEDLES — Cp Medical
- FN NEEDLES — Cp Medical
- FN NEEDLES — Cp Medical
- FN NEEDLES — Cp Medical
- Theragenics — THERAGENICS CORP.
- Theragenics — THERAGENICS CORP.
- Theragenics — THERAGENICS CORP.
- Theragenics — THERAGENICS CORP.
- Theragenics — THERAGENICS CORP.
- Theragenics — THERAGENICS CORP.
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
- Theragenics Corp.
Sources (1)
- FDA UDI 2881491e-030f-441f-be0c-636e9fa7ee68 33 fields · synced May 30, 2026