Identity
- Trade Name
- Non-CT Miami Docking Unit Assembly, BEBIG FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, manual FDA UDI
- Model / Reference
- 1410-36 FDA UDI
Identifiers
- Catalog Number
- 1410-36 FDA UDI
- Primary DI / UDI-DI
- 00817330024138 FDA UDI
- 510(k) Number
- K020176 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- General-purpose brachytherapy system applicator, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Category: General-purpose brachytherapy system applicator, manual
Non-CT Miami Docking Unit Assembly, BEBIG by Mick Radio Nuclear Instrument, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose brachytherapy system applicator, manual.
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- TheraSeed® — BARD BRACHYTHERAPY, INC · Class II
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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, BEBIG — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Miami Applicator Set, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mick Radio Nuclear Instrument, Inc
Sources (1)
- FDA UDI 0afec9a2-dfb3-43c6-91f7-c01b76df6889 34 fields · synced Jun 1, 2026