Identity
- Trade Name
- CT/MR Miami Applicator Set - BEBIG EUDAMEDCT/MR Miami Applicator Set, BEBIG FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, manual FDA UDI
- Device Name
- CT/MR Miami Applicator EUDAMED
- Model / Reference
- 1410 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 1410 FDA UDI
- Primary DI / UDI-DI
- 00817330024114 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00817330024114 EUDAMED
- 510(k) Number
- K020176 FDA UDI
- 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
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: General-purpose brachytherapy system applicator, manual
CT/MR Miami Applicator Set, BEBIG by Mick Radio Nuclear Instrument, Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K020176 also covers:
- 30 Degree Tandem Varian Comp Miami — MICK RADIO NUCLEAR INSTRUMENT, INC
- Build-up Cap for Ring & Tandem, 5.0mm (black) — MICK RADIO NUCLEAR INSTRUMENT, INC
- Build-up Cap for Ring & Tandem, 7.5mm (white) — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Miam BuildUp Cap, 25mm, domed, Varian — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Miam BuildUp Cap, 25mm, domed, Varian — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Miam BuildUp Cap, 30mm, domed, Varian — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Miam BuildUp Cap, 35mm, domed, Varian — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Miam BuildUp Cap, 40mm, domed, Varian — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Miami Appl Body w Collet, Varian — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Miami Appl Body w/ Collet, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Miami Applicator Set, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Miami Applicator, Varian — MICK RADIO NUCLEAR INSTRUMENT, INC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mick Radio Nuclear Instrument, Inc
Sources (2)
- FDA UDI 7eea0e9c-a532-4ffe-aeb1-79ec99cda764 34 fields · synced Aug 3, 2026
- EUDAMED 7f3c5eb6-e9ea-47fa-a852-5dc89dbf11fe 61 fields · synced Aug 3, 2026