FDA.reportPublic FDA data

Mick 5mm gold fiduciary marker,18G, 3 pack (30pc)

Primary DI
00817330021786
Brand
Mick 5mm gold fiduciary marker,18G, 3 pack (30pc)
Company
MICK RADIO NUCLEAR INSTRUMENT, INC
Model
0811-53
Catalog number
0811-53
Published
2016-12-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K890341000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K890341000MICK 200-TP AND MICK TP NEEDLEMick Radio-Nuclear Instruments, Inc.1989-03-14IWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817330021786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817330021786008173300217868173300217860817330021786

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

Regulatory Flags#

DUNS number
073260622
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
B16556440328083126176Implant NeedleLiberty Medical , Inc.IWJ2026-08-18
B16556450328083126173Single Leader Catheter with LuerLiberty Medical , Inc.IWJ2026-08-18
B16556500328083126172Small Prostate TemplateLiberty Medical , Inc.IWJ2026-08-18
B16557060328083126147Flexi-NeedleLiberty Medical , Inc.IWJ2026-08-18
B1655765032802312606Flexi-NeedleLiberty Medical , Inc.IWJ2026-08-18
B16558000328043026121Small Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-08-18
B16559100328083126175ButtonsLiberty Medical , Inc.IWJ2026-08-18
B16560390328023126165Single Leader Catheter with LuerLiberty Medical , Inc.IWJ2026-08-18
B16570160328083126144Flexi-NeedleLiberty Medical , Inc.IWJ2026-08-18
B16570170328083126159Flexi-NeedleLiberty Medical , Inc.IWJ2026-08-18
B16570170328083126174Flexi-NeedleLiberty Medical , Inc.IWJ2026-08-18
B1657017032808312646Flexi-NeedleLiberty Medical , Inc.IWJ2026-08-18
B16570550328083126017Gynecological TemplateLiberty Medical , Inc.IWJ2026-08-18
B16570940328083126166AdapterLiberty Medical , Inc.IWJ2026-08-18
B16570940328083126177AdapterLiberty Medical , Inc.IWJ2026-08-18
00841365121593Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-08-03
00841365121609Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-08-03
00841436125451Classic StepperCIVCO MEDICAL INSTRUMENTS CO., INC.IWJ2026-07-23
B16556052032806302620Large Prostate TemplateLiberty Medical , Inc.IWJ2026-07-08
B16556510328063026080Medium Prostate TemplateLiberty Medical , Inc.IWJ2026-07-08
B16556630328063026137Intrauterine TandemLiberty Medical , Inc.IWJ2026-07-08
B16557060328060026140Flexi-NeedleLiberty Medical , Inc.IWJ2026-07-08
B16558000327103126049Small Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-07-08
B16558010328043026108Medium Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-07-08
B16558100328103126034Small Prostate Brachytherapy Kit-metal hubLiberty Medical , Inc.IWJ2026-07-08
B16559070328063026073ButtonsLiberty Medical , Inc.IWJ2026-07-08
B16559080328063026059ButtonsLiberty Medical , Inc.IWJ2026-07-08
B16559100328063026111ButtonsLiberty Medical , Inc.IWJ2026-07-08
B16570160328063026139Flexi-NeedleLiberty Medical , Inc.IWJ2026-07-08
B1657060328063026115Flexi-NeedleLiberty Medical , Inc.IWJ2026-07-08