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CT/MR Contour Prostate Template, Small Matrix B&K 1.65mm - EZ BEBIG
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 1204-02-1.65
Identity
- Trade Name
- CT/MR Contour Prostate Template (small) BK, 1.65mm EUDAMEDCT/MR Contour Prostate Template, Small Matrix B&K 1.65mm - EZ BEBIG FDA UDICT/MR Contour Prostate Template, HDR Sm B&K 1.65mm FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, manual FDA UDI
- Device Name
- CT/MR Contour Prostate Template EUDAMED
- Model / Reference
- 1204-02-1.65 EUDAMED1204-02-EZ-1.65 FDA UDI1204-02-1.65MM FDA UDI
Identifiers
- Catalog Number
- 1204-02-EZ-1.65 FDA UDI1204-02-1.65MM FDA UDI
- Primary DI / UDI-DI
- 00817330023148 EUDAMEDFDA UDI00817330027887 FDA UDI
- Basic UDI-DI
- B-00817330023148 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 UDIFDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Category: General-purpose brachytherapy system applicator, manual
CT/MR Contour Prostate Template, Small Matrix B&K 1.65mm - EZ BEBIG by Mick Radio Nuclear Instrument, Inc — Class II — MDD, FDA UDI — listed in FDA GUDID…
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Also classified as General-purpose brachytherapy system applicator, manual.
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- TheraSeed® — BARD BRACHYTHERAPY, INC · Class II
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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 |
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Manufacturer
- Manufacturer
- Mick Radio Nuclear Instrument, Inc
Sources (3)
- FDA UDI 087edd63-061b-4ff8-bb50-1065964e0677 34 fields · synced Oct 6, 2026
- FDA UDI 1aa2498a-e263-411e-8a42-cb9a74535b50 34 fields · synced May 30, 2026
- EUDAMED 5051f4a4-f143-4f33-ba08-0be1395cffbb 61 fields · synced Aug 4, 2026