FDA.reportPublic FDA data

Prostate Seeding Set

Primary DI
20886333004465
Brand
Prostate Seeding Set
Company
ARGON MEDICAL DEVICES, INC.
Model
500518200X
Catalog number
500518200X
Device description
Prostate Seeding Set 18ga ETW x 20cm
Published
2022-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886333004465PackageGS125In Commercial Distribution
00886333004461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633300446520886333004465
00886333004461008863330044618863330044610886333004461

GMDN Terms#

Term, Definition table
TermDefinition
Prostate brachytherapy system applicator, manualA manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the prostate. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, endoscopically guided or diagnostic imaging system guided placement, and/or removal of single or multiple radioactive sources at a treatment site within the prostate. The device may be a fixed design or designed to accommodate individual patient source placement configurations and includes prostate applicators such as hollow needles, tubes or catheters, used in manual brachytherapy applications.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry and away from sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags#

DUNS number
140727624
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20886333227864V-Stick Vascular Access Set391504300E391504300E2026-03-20
20886333227871V-Stick Vascular Access Set391505300E391505300E2026-03-20
20886333227888V-Stick Vascular Access Set 391505400E391505400E2026-03-20
20886333227895V-Stick Vascular Access Set391604300E391604300E2026-03-20
20886333227901V-Stick Vascular Access Set 391605300E391605300E2026-03-20
20886333227918V- Stick Vascular Access Set391605400E391605400E2026-03-20
20886333227925V-Stick Vascular Access Set391504400E391504400E2026-03-20
20886333227932V-Stick Vascular Access Set391604400E391604400E2026-03-20
20886333209259Tumescent Infiltration Kit1981431981432025-05-02
10886333227584OneStic Micro-Access Introducer4978864978862025-05-02
20886333227116Bone Access NeedleDBANJ0806TLDBANJ0806TL2023-01-03
20886333227659Transfermoral Transcaval Liver Biopsy SystemTF-18CTF-18C2024-08-12
20886333227499ClosureFast GuidewireGW-025-260-1.5JGW-025-260-1.5J2024-07-29
20886333227505ClosureFast GuidewireGW-035-45GW-035-452024-07-29
20886333227512ClosureFast Introducer Sheath IS-7F07IS-7F072024-07-29
20886333227529ClosureFast Introducer Sheath IS-7F11IS-7F112024-07-29
20886333227550ClosureFast Micro Puncture MPK-4FMPK-4F2024-07-29
20886333227567ClosureFast Micro PunctureMPK-5FMPK-5F2024-07-29
20886333227574ClosureFast Tumescent Infiltration KitTIK-01TIK-012024-07-29
20886333227444ClosureFast Arterial NeedleAN-19GEAN-19GE2024-07-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841365121494Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-03-02
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00841365121463Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-02-26
00841365121470Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-02-26
00841365121487Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-02-26
B16556330628022825032Flexi-NeedleLiberty Medical , Inc.IWJ2026-02-25
B16556510328022825225Medium Prostate TemplateLiberty Medical , Inc.IWJ2026-02-25
B16556620328013125172Intrauterine TandemLiberty Medical , Inc.IWJ2026-02-25
B16558110327103126019Medium Prostate Brachytherapy Kit-metal hubLiberty Medical , Inc.IWJ2026-02-25
B16558110327123126026Medium Prostate Brachytherapy Kit-metal hubLiberty Medical , Inc.IWJ2026-02-25
B16559130328022824072Flexi-NeedleLiberty Medical , Inc.IWJ2026-02-25
B16570160328013125207Flexi-NeedleLiberty Medical , Inc.IWJ2026-02-25
B16570160328022825246Flexi-NeedleLiberty Medical , Inc.IWJ2026-02-25
B16570170328013125247Flexi-NeedleLiberty Medical , Inc.IWJ2026-02-25
B16570940328022825055AdapterLiberty Medical , Inc.IWJ2026-02-25
B16570940328022826027AdapterLiberty Medical , Inc.IWJ2026-02-25
00841365121449Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-02-06
00841365121456Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-02-06
B16556510328013126005Medium Prostate TemplateLiberty Medical , Inc.IWJ2026-01-16
B1655664032801312607Flexi-NeedleLiberty Medical , Inc.IWJ2026-01-16
B16557060328013125220Flexi-NeedleLiberty Medical , Inc.IWJ2026-01-16
B16557640328013125196Flexi-NeedleLiberty Medical , Inc.IWJ2026-01-16
B16558000327073125209Small Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-01-16
B16559250328013125180Intrauterine TandemLiberty Medical , Inc.IWJ2026-01-16
B16570940328013126011AdapterLiberty Medical , Inc.IWJ2026-01-16
00841365121432Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-01-13
B16556210327123125097Implant NeedleLiberty Medical , Inc.IWJ2026-01-05
B165563503271231251321Implant NeedleLiberty Medical , Inc.IWJ2026-01-05
B16556520327123125019Large Prostate TemplateLiberty Medical , Inc.IWJ2026-01-05