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CT/MR-Vag. Cylinder with variable length D=40mm L=140mm
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref LCZ07-05
Identity
- Trade Name
- CT/MR-Vag. Cylinder with variable length D=40mm L=140mm EUDAMEDFDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- CT/MR-Vag. Cylinder with variable length EUDAMED
- Model / Reference
- LCZ07-05 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- LCZ07-05 FDA UDI
- Primary DI / UDI-DI
- 04065983002379 EUDAMED04049223107970 FDA UDI
- Basic UDI-DI
- B-04065983002379 EUDAMED
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
CT/MR-Vag. Cylinder with variable length D=40mm L=140mm by Eckert & Ziegler BEBIG GmbH — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Eckert & Ziegler BEBIG GmbH
Sources (2)
- FDA UDI 260f843b-f9e4-40d7-bed3-27653f84adba 35 fields · synced Oct 6, 2026
- EUDAMED a32fb7ac-5e8c-4d6f-8491-d3014a453969 61 fields · synced Jul 18, 2026