CT/MR M.A.C. Interstitial GYN Template, 2.0mmVarian
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- CT/MR M.A.C. Interstitial GYN Template,2.0mm Elekta EUDAMEDCT/MR M.A.C. Interstitial GYN Template,2.0mm Varian EUDAMEDCT/MR M.A.C. Interstitial GYN Template,2.0mmVarian FDA UDICT/MR M.A.C. Interstitial GYN Template,2.0mmElekta FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, manual FDA UDI
- Device Name
- CT/MR M.A.C. Interstitial GYN Template Elekta EUDAMEDCT/MR M.A.C. Interstitial GYN Template Varian EUDAMED
- Model / Reference
- 1211-2.0 EUDAMEDFDA UDI1505-2.0 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 1211-2.0 FDA UDI1505-2.0 FDA UDI
- Primary DI / UDI-DI
- 00817330023629 EUDAMEDFDA UDI00817330024176 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00817330024176 EUDAMEDB-00817330023629 EUDAMED
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- General-purpose brachytherapy system applicator, manual FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: General-purpose brachytherapy system applicator, manual
CT/MR M.A.C. Interstitial GYN Template, 2.0mmVarian by Mick Radio Nuclear Instrument, Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
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
- Mick Radio Nuclear Instrument, Inc
Sources (4)
- FDA UDI 63d0f3a5-1066-45c3-9fc3-cf97fe7a1aa3 33 fields · synced Oct 6, 2026
- FDA UDI 94ebb117-bd04-409d-9f37-868659d081ec 33 fields · synced May 30, 2026
- EUDAMED 5f8610c8-53c3-44f8-910b-329d3423ec6a 61 fields · synced Jul 11, 2026
- EUDAMED 41d940e2-79e1-4292-91c1-e0a9000e4270 61 fields · synced Jul 19, 2026