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CT/MR Contour Prostate Template Insert, 18G, lrg

FDA UDI

Class II (US FDA UDI)

by Mick Radio Nuclear Instrument, Inc

Identity

Trade Name
CT/MR Contour Prostate Template Insert, 18G, lrg FDA UDI
Generic Name
General-purpose brachytherapy system applicator, manual FDA UDI
Model / Reference
1206-03-18G FDA UDI

Identifiers

Catalog Number
1206-03-18G FDA UDI
Primary DI / UDI-DI
00817330023414 FDA UDI
510(k) Number
K993400 FDA UDI
FDA Product Code
JAQ FDA UDI
GMDN Term
General-purpose brachytherapy system applicator, manual FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5700 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

No

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

Category: General-purpose brachytherapy system applicator, manual

CT/MR Contour Prostate Template Insert, 18G, lrg by Mick Radio Nuclear Instrument, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose brachytherapy system applicator, manual.

Cleared under the same submission

K993400 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mick Radio Nuclear Instrument, Inc

Sources (1)

  • FDA UDI 6257a117-4682-4078-be2f-7d8e1110b267 34 fields · synced May 30, 2026