FDA.reportPublic FDA data

MICK 3mm Gold Fiduciary Marker, 17G Single

Primary DI
00817330027733
Brand
MICK 3mm Gold Fiduciary Marker, 17G Single
Company
MICK RADIO NUCLEAR INSTRUMENT, INC
Model
0705-01
Catalog number
0705-01
Published
2016-11-08
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
00817330027733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817330027733008173300277338173300277330817330027733

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
073260622
Device count
1
DM exempt
true
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

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B16556500328083126172Small Prostate TemplateLiberty Medical , Inc.IWJ2026-08-18
B16557060328083126147Flexi-NeedleLiberty Medical , Inc.IWJ2026-08-18
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B16558000328043026121Small Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-08-18
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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
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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
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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
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