Identity
- Trade Name
- Smit Sleeve w/Titanium Ring 90mm FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, manual FDA UDI
- Model / Reference
- 0311-90mm FDA UDI
Identifiers
- Catalog Number
- 0311-90mm FDA UDI
- Primary DI / UDI-DI
- 00817330027689 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
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
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
Smit Sleeve w/Titanium Ring 90mm by Mick Radio Nuclear Instrument, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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:
- 5.0mm Build Up Caps, single-use, Split-Ring (6pc) — MICK RADIO NUCLEAR INSTRUMENT, INC
- 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
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 eca8928d-e512-494a-9e9c-01f6f36aaedc 34 fields · synced May 31, 2026