Identity
- Trade Name
- Mick 3mm gold fiduciary marker,17G,single (10pc) FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, manual FDA UDI
- Model / Reference
- 0705-03 FDA UDI
Identifiers
- Catalog Number
- 0705-03 FDA UDI
- Primary DI / UDI-DI
- 00817330021434 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
No
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, 17G, single (10pc) by Mick Radio Nuclear Instrument, Inc — Class I — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K890341 also covers:
- MICK 3mm Gold Fiduciary Marker 18 G Single — MICK RADIO NUCLEAR INSTRUMENT, INC
- 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 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 0ce93130-ddca-4542-92a5-91c9d929eec6 34 fields · synced May 30, 2026