CT Vaginal Segmented Appl Set-closed dome, Nucltrn 0712-MS

GUDID 00817330021571

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 ID00817330021571
NIH Device Record Keyd01408f0-5af5-48b1-ab30-6266f614d78c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCT Vaginal Segmented Appl Set-closed dome, Nucltrn
Version Model Number0712-MS
Catalog Number0712-MS
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 Batchfalse
Serial Numbertrue
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
GS100817330021571 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, Applicator, Radionuclide, Remote-Controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817330021571]

Moist Heat or Steam Sterilization


[00817330021571]

Moist Heat or Steam Sterilization


[00817330021571]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-14

Devices Manufactured by MICK RADIO NUCLEAR INSTRUMENT, INC

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00817330027696 - Smit Sleeve w/Titanium Ring 40mm2019-08-06
00817330027870 - CT/MR Miami Buildup Cap, 40mm,open end, Varian2019-08-06
00817330027979 - CT/MR M.A.C. Vaginal Obturator 14cm Length with Lock Screw 1.65G2019-08-06
00817330020000 - Henschke Ovoids With Tungsten Segments & Caps Set2018-07-06
00817330020017 - Miami-Style Applicator Set, Varian (Non-CT/MR)2018-07-06

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