FDA.reportPublic FDA data

CT/MR 2/3 Channel Endometrial Applicator Set, Nucl

Primary DI
00817339922776
Brand
CT/MR 2/3 Channel Endometrial Applicator Set, Nucl
Company
MICK RADIO NUCLEAR INSTRUMENT, INC
Model
0916
Catalog number
0916
Published
2017-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IWJSystem, Applicator, Radionuclide, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWJSystem, Applicator, Radionuclide, ManualRadiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K871216000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K871216000HILARIS-NORI ENDOMETRIAL APPLICATORMick Radio-Nuclear Instruments, Inc.1987-07-21IWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817339922776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817339922776008173399227768173399227760817339922776

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose brachytherapy system applicator, manualA general-purpose brachytherapy applicator designed to facilitate delivery of radiation therapy treatments that are not specific to a particular anatomical region. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, topical placement, endoscopically guided placement or diagnostic imaging system guided placement, and removal of single or multiple radioactive sources at a treatment site. The device may be a fixed design or designed to facilitate the creation of variable physical configurations or individual patient source placement configurations and includes general-purpose applicators such as hollow needles, tubes or catheters, ovoids or tandems.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
073260622
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817330028082CT/MR M.A.C. Template - 14cm Vaginal Obturator with Lock Screw - 2.0mm Needle0918-05-2.02023-11-02
00817330022776CT/MR 2/3 Channel Endometrial Applicator Set, Nucletron091609162017-01-24
00817330026774Pathfinder 15.5G, 20cm9807PFO-15.5-209807PFO-15.5-202017-01-11
00817330027696Smit Sleeve w/Titanium Ring 40mm0311-40mm0311-40mm2016-11-08
00817330027870CT/MR Miami Buildup Cap, 40mm,open end, Varian0904-02-400904-02-402017-01-30
00817330027979CT/MR M.A.C. Vaginal Obturator 14cm Length with Lock Screw 1.65G0918-14-1.650918-15-1.652017-05-15
00817330020000Henschke Ovoids With Tungsten Segments & Caps Set6402-056402-052016-10-05
00817330020017Miami-Style Applicator Set, Varian (Non-CT/MR)010401042016-10-14
00817330020031CT/MR Miami Build-Up Cap/ Obturator - 30mm0104-02-300104-02-302016-10-14
00817330020062Extended Lock Nut0104-100104-102016-10-14
00817330020079Miami Stump Plug Insertion Tool0104-290104-292016-10-14
00817330020086Miami Stump Plug0104-300104-302016-10-14
00817330020109Non-CT Miami Build-Up Cap Domed 25mm Varian0104-40-300104-40-302016-10-14
00817330020123Non-CT Miami Build-Up Cap Domed 35mm Varian0104-40-350104-40-352016-10-14
00817330020130Non-CT Miami Build-Up Cap Domed 40mm Varian0104-40-400104-40-402016-10-14
00817330020147Build-up Cap for Ring & Tandem, 5.0mm (black)0213-63-10213-63-12016-10-14
00817330020154Build-up Cap for Ring & Tandem, 7.5mm (white)0213-63-20213-63-22016-10-14
00817330020161CT/MR Ring & Tandem Set, 32mm, 30°,45°,60°, Varian040704072016-09-20
00817330020185CT/MR Ring & Tandem Set, 32mm Ring, 30ø, Varian0407-300407-302016-09-20
00817330020192CT/MR Ring & Tandem IU Tube, 30ø, 2cm, Varian0407-30-20407-30-22016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B16556330328053126035Flexi-NeedleLiberty Medical , Inc.IWJ2026-06-01
B1655635032805302533Implant NeedleLiberty Medical , Inc.IWJ2026-06-01
B1655662032805302615Intrauterine TandemLiberty Medical , Inc.IWJ2026-06-01
B16558010327123126103Medium Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-06-01
B16558010328010026067Medium Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-06-01
B165580203270931260031Large Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-06-01
B16558110328022826066Medium Prostate Brachytherapy Kit-metal hubLiberty Medical , Inc.IWJ2026-06-01
B16559050328053126091ButtonsLiberty Medical , Inc.IWJ2026-06-01
B16559060328053026074ButtonsLiberty Medical , Inc.IWJ2026-06-01
B16559090328053026060ButtonsLiberty Medical , Inc.IWJ2026-06-01
B16559100328053026079ButtonsLiberty Medical , Inc.IWJ2026-06-01
B16570160328053126101Flexi-NeedleLiberty Medical , Inc.IWJ2026-06-01
B16570170328053126102Flexi-NeedleLiberty Medical , Inc.IWJ2026-06-01
B16570940328053126107AdapterLiberty Medical , Inc.IWJ2026-06-01
00841365121579Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-05-29
00841365121562Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-05-21
00841365121555Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-05-15
B201CGSG140Clear Guide SteriGRIDCLEAR GUIDE MEDICAL, INC.IWJ2026-05-11
00841365121548Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-05-06
B165565003280430252241Small Prostate TemplateLiberty Medical , Inc.IWJ2026-05-01
B16556510328043026077Medium Prostate TemplateLiberty Medical , Inc.IWJ2026-05-01
B165576403280430260101Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
B16557640328043026081Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
B16557650328040025244Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
B16559060328043026048ButtonsLiberty Medical , Inc.IWJ2026-05-01
B16559070328043025007ButtonsLiberty Medical , Inc.IWJ2026-05-01
B16570160328043026056Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
B16570170328043026057Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
00841365121524Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-04-29
00841365121517Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-04-16