← Back to catalogue

CT/MR Contour Prostate Template, HDR Sm B&K 1.65mm

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 1204-02-1.65

by Mick Radio Nuclear Instrument, Inc

Identity

Trade Name
CT/MR Contour Prostate Template (small) BK, 1.65mm EUDAMED
CT/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 EUDAMED
1204-02-1.65MM FDA UDI

Identifiers

Catalog Number
1204-02-1.65MM FDA UDI
Primary DI / UDI-DI
00817330023148 EUDAMEDFDA 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 EUDAMED
Class 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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Safe FDA UDI

CT/MR Contour Prostate Template, HDR Sm B&K 1.65mm by Mick Radio Nuclear Instrument, Inc — Class II — FDA UDI — listed in FDA GUDID, EUDAMED

Cleared under the same submission

K993400 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Mick Radio Nuclear Instrument, Inc

Sources (2)

  • FDA UDI 1aa2498a-e263-411e-8a42-cb9a74535b50 34 fields · synced Oct 8, 2026
  • EUDAMED 5051f4a4-f143-4f33-ba08-0be1395cffbb 61 fields · synced Aug 4, 2026