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MR HDR Contour Prostate template, HDR SMN, 18G
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 1206-04-18
Identity
- Trade Name
- CT/MR Contour Prostate Template (large) Siemens, 18G EUDAMEDMR HDR Contour Prostate template, HDR SMN, 18G FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, manual FDA UDI
- Device Name
- CT/MR Contour Prostate Template EUDAMED
- Model / Reference
- 1206-04-18 EUDAMED1206-04-18G FDA UDI
Identifiers
- Catalog Number
- 1206-04-18G FDA UDI
- Primary DI / UDI-DI
- 00817330023452 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00817330023452 EUDAMED
- 510(k) Number
- K993400 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- General-purpose brachytherapy system applicator, manual FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Category: General-purpose brachytherapy system applicator, manual
MR HDR Contour Prostate template, HDR SMN, 18G by Mick Radio Nuclear Instrument, Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
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
K993400 also covers:
- Blundt End Flexiguide 4F/18Gx45cm — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Contour Prostate Template Insert, 1.65mm lrg — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Contour Prostate Template Insert, 17G, lrg — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Contour Prostate Template Insert, 18G, lrg — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Contour Prostate Template Insert, 2mm lrg — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Contour Prostate Template, HDR Large Matrix B&K, 1.65mm — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Contour Prostate Template, HDR Large Matrix B&K, 17G — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Contour Prostate Template, HDR Sm B&K 15.5G — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Contour Prostate Template, HDR Sm B&K 15.5G — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Contour Prostate Template, HDR Sm B&K 15.5G — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Contour Prostate Template, HDR Sm B&K 17G — MICK RADIO NUCLEAR INSTRUMENT, INC
- CT/MR Contour Prostate Template, HDR Sm B&K 17G — MICK RADIO NUCLEAR INSTRUMENT, INC
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| 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 (2)
- FDA UDI 96daf896-7c9e-4d79-ac4e-adc0d00416eb 34 fields · synced Jul 10, 2026
- EUDAMED b75c9d6b-e61c-46d4-9e4f-3c1d04c50092 61 fields · synced Jul 10, 2026