Identity
- Trade Name
- 5.0mm Build Up Caps, single-use, Split-Ring (6pc) FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, manual FDA UDI
- Model / Reference
- 0605-21-01 FDA UDI
Identifiers
- Catalog Number
- 0605-21-01 FDA UDI
- Primary DI / UDI-DI
- 00817330021014 FDA UDI
- 510(k) Number
- K030110 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
Yes
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
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
5.0mm Build Up Caps, single-use, Split-Ring (6pc) by Mick Radio Nuclear Instrument, Inc — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as General-purpose brachytherapy system applicator, manual.
- AccuBoost — ADVANCED RADIATION THERAPY, LLC · Class I
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC · Class II
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC · Class II
- TheraSeed® — BARD BRACHYTHERAPY, INC · Class II
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC · Class II
- Best Medical International — Best Medical International, Inc. · Class I
- Buttons — LIBERTY MEDICAL INC · Class I
- Adapter — LIBERTY MEDICAL INC · Class I
Cleared under the same submission
K030110 also covers:
- BuildUP Cap for Rng & Tand, 7.5mm (white) — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT Vaginal Cylinder, 35mm cylinder — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR R&T IU Tube, 30ø, 10.0cm, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR R&T IU Tube, 30ø, 2.0cm, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR R&T IU Tube, 30ø, 4.0cm, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR R&T IU Tube, 30ø, 7.0cm, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR R&T IU Tube, 30ø, 8.0cm, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR R&T IU Tube, 45ø, 10.0cm, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR R&T IU Tube, 45ø, 2.0cm, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR R&T IU Tube, 45ø, 4.0cm, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR R&T IU Tube, 45ø, 5.0cm, Nucletron — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR R&T IU Tube, 45ø, 6.0cm, 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 4f4f0a77-ce65-4f08-be81-90dd68a15dcc 34 fields · synced Jun 8, 2026