FDA.reportPublic FDA data

Best Medical International

Primary DI
00841365110658
Brand
Best Medical International
Company
BEST MEDICAL INTERNATIONAL, INC.
Model
423-12
Published
2015-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K904933000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K904933000VARIOUS AFTERLOADING APPLICATORSBest Assoc. Corp.1991-01-04IWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841365110658PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841365110658008413651106588413651106580841365110658

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
086352655
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
00841365121562Best Medical International180-602026-05-21
00841365121555Best Medical International2451-152026-05-15
00841365121548Best Medical International793-1402026-05-06
00841365121531Best Medical International10113-46-32026-05-04
00841365121524Best Medical International747-522026-04-29
00841365121517Best Medical International1525-29.5-12026-04-16
00841365121500Best Medical International10113-43-12026-04-03
00841365121494Best Medical International771-29.42026-03-02
00841365121463Best Medical International1406-1-452026-02-26
00841365121470Best Medical International1406-2-452026-02-26
00841365121487Best Medical International1406-3-452026-02-26
00841365121449Best Medical International2117-31.6-12026-02-06
00841365121456Best Medical International2119-31.62026-02-06
00841365121432Best Medical International423-62026-01-13
00841365121425Best Medical International1512-1-32025-12-16
00841365121418Best Medical International2381-25-12025-11-28
00841365121401Best Medical International2448-25-52025-11-24
00841365121395Best Medical International2162-25-42025-10-31
00841365121388Best Medical International1013-5-12025-10-20
00841365121371Best Medical International2003-15.5-12025-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
B16556320328033123181Flexi-NeedleLiberty Medical , Inc.IWJ2026-03-26
B16556470328033126031Catheter CapsLiberty Medical , Inc.IWJ2026-03-26
B16557060328033126014Flexi-NeedleLiberty Medical , Inc.IWJ2026-03-26
B16558000327093126001Small Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-03-26
B16558010327093026002Medium Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-03-26
B16558110328013126041Medium Prostate Brachytherapy Kit-metal hubLiberty Medical , Inc.IWJ2026-03-26
B16559050328033126021ButtonsLiberty Medical , Inc.IWJ2026-03-26
B16559060328033126022ButtonsLiberty Medical , Inc.IWJ2026-03-26
B165590803280331ButtonsLiberty Medical , Inc.IWJ2026-03-26
B16559090328033125229ButtonsLiberty Medical , Inc.IWJ2026-03-26
B16559100328033126036ButtonsLiberty Medical , Inc.IWJ2026-03-26
B16559130328033126030Flexi-NeedleLiberty Medical , Inc.IWJ2026-03-26
B16559140328033125094Flexi-NeedleLiberty Medical , Inc.IWJ2026-03-26
B16559250328033126013Intrauterine TandemLiberty Medical , Inc.IWJ2026-03-26
B16570160328033126029Flexi-NeedleLiberty Medical , Inc.IWJ2026-03-26