Identity
- Trade Name
- Dummy, silver, type CCY FDA UDI
- Generic Name
- Manual brachytherapy source, temporary placement FDA UDI
- Model / Reference
- AGD.A22 FDA UDI
Identifiers
- Catalog Number
- AGD.A22 FDA UDI
- Primary DI / UDI-DI
- 04049223104795 FDA UDI
- 510(k) Number
- K931393 FDA UDI
- FDA Product Code
- KXK FDA UDI
- GMDN Term
- Manual brachytherapy source, temporary placement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5730 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dummy, silver, type CCY by Eckert & Ziegler BEBIG GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K931393 also covers:
- Dummy, silver, type CCA — Eckert & Ziegler BEBIG GmbH
- Dummy, silver, type CCB — Eckert & Ziegler BEBIG GmbH
- Dummy, silver, type CCC — Eckert & Ziegler BEBIG GmbH
- Dummy, silver, type CCD — Eckert & Ziegler BEBIG GmbH
- Dummy, silver, type CCX — Eckert & Ziegler BEBIG GmbH
- Dummy, silver, type CGD — Eckert & Ziegler BEBIG GmbH
- Dummy, silver, type CIA — Eckert & Ziegler BEBIG GmbH
- Dummy, silver, type CIB — Eckert & Ziegler BEBIG GmbH
- Dummy, silver, type COB — Eckert & Ziegler BEBIG GmbH
- Dummy, silver, type COC — Eckert & Ziegler BEBIG GmbH
- Dummy, silver, type COD — Eckert & Ziegler BEBIG GmbH
- Dummy, silver, type COE — Eckert & Ziegler BEBIG GmbH
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
- Eckert & Ziegler BEBIG GmbH
Sources (1)
- FDA UDI a9f82a4e-6d23-4cbd-8aeb-98e2789d3c15 37 fields · synced May 30, 2026