Smit Sleeve w/Titanium Ring 50mm 0311-50mm

GUDID 00817330027795

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 ID00817330027795
NIH Device Record Key9484bc1e-9508-4a48-bc33-ec68c993be0c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmit Sleeve w/Titanium Ring 50mm
Version Model Number0311-50mm
Catalog Number0311-50mm
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 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
GS100817330027795 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, Applicator, Radionuclide, Remote-Controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817330027795]

Moist Heat or Steam Sterilization


[00817330027795]

Moist Heat or Steam Sterilization


[00817330027795]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-17

Devices Manufactured by MICK RADIO NUCLEAR INSTRUMENT, INC

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00817330020017 - Miami-Style Applicator Set, Varian (Non-CT/MR)2018-07-06

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