CT/MR Contour Prostate template HDR B&K 1.65mm lg 1206-02-16G

GUDID 00817330023346

MICK RADIO NUCLEAR INSTRUMENT, INC

General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual
Primary Device ID00817330023346
NIH Device Record Keydf0ffe2c-7708-4510-a1ad-78640bd432fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameCT/MR Contour Prostate template HDR B&K 1.65mm lg
Version Model Number1206-02-16G
Catalog Number1206-02-16G
Company DUNS073260622
Company NameMICK RADIO NUCLEAR INSTRUMENT, INC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817330023346 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, Applicator, Radionuclide, Remote-Controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817330023346]

Moist Heat or Steam Sterilization


[00817330023346]

Moist Heat or Steam Sterilization


[00817330023346]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-20

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