Miami Style Applicator Body, Acetal AL07370002

GUDID 00817330027054

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 ID00817330027054
NIH Device Record Key3a790054-14d0-4c8e-8117-15c1364b5aa6
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiami Style Applicator Body, Acetal
Version Model NumberAL07370002
Catalog NumberAL07370002
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
GS100817330027054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, Applicator, Radionuclide, Remote-Controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817330027054]

Moist Heat or Steam Sterilization


[00817330027054]

Moist Heat or Steam Sterilization


[00817330027054]

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

00817330028082 - CT/MR M.A.C. Template - 14cm Vaginal Obturator with Lock Screw - 2.0mm Needle2023-11-10
00817330022776 - CT/MR 2/3 Channel Endometrial Applicator Set, Nucletron2019-08-06
00817330026774 - Pathfinder 15.5G, 20cm2019-08-06
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.