Identity
- Trade Name
- MICK 3mm Gold Fiduciary Marker 18 G Single FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, manual FDA UDI
- Model / Reference
- 0811-51 FDA UDI
Identifiers
- Catalog Number
- 0811-51 FDA UDI
- Primary DI / UDI-DI
- 00817330027740 FDA UDI
- 510(k) Number
- K890341 FDA UDI
- FDA Product Code
- IWJ FDA UDI
- GMDN Term
- General-purpose brachytherapy system applicator, manual FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.5650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose brachytherapy system applicator, manual
MICK 3mm Gold Fiduciary Marker 18 G Single by Mick Radio Nuclear Instrument, Inc — Class I — 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
K890341 also covers:
- MICK 3mm Gold Fiduciary Marker, 17G Single — MICK RADIO NUCLEAR INSTRUMENT, INC
- MICK Implant Needle 17Gx177.8mm (10pcs) — MICK RADIO NUCLEAR INSTRUMENT, INC
- MICK TP Needle, 17G, 20cm, Disp, (25pc) — MICK RADIO NUCLEAR INSTRUMENT, INC
- MICK TP Needle, 17G, 25cm, Disp, (25pc) — MICK RADIO NUCLEAR INSTRUMENT, INC
- MICK TP Needle, 18G, 10cm, Disp, (25pc) — MICK RADIO NUCLEAR INSTRUMENT, INC
- MICK TP Needle, 18G, 20cm, Disp, (25pc) — MICK RADIO NUCLEAR INSTRUMENT, INC
- MICK TP Needle, 18G, 25cm, Disp, (25pc) — MICK RADIO NUCLEAR INSTRUMENT, INC
- Mick 3mm gold fiduciary marker, 17G, single (10pc) — MICK RADIO NUCLEAR INSTRUMENT, INC
- Mick 5mm gold fiduciary marker, 17G, single (10pc) — MICK RADIO NUCLEAR INSTRUMENT, INC
- Mick 5mm gold fiduciary marker, 18G, 3 pack (30pc) — 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 I | 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 9b28acf5-49af-443f-a397-f5761d4560ca 34 fields · synced May 30, 2026