FDA.reportPublic FDA data

Best Medical International

Primary DI
00841365118593
Brand
Best Medical International
Company
BEST MEDICAL INTERNATIONAL, INC.
Model
7001
Published
2020-12-29
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
JAQSystem, Applicator, Radionuclide, Remote-Controlled

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWJSystem, Applicator, Radionuclide, ManualRadiology1
JAQSystem, Applicator, Radionuclide, Remote-ControlledRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042586000
K904933000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042586000BEST BREAST BRACHYTHERAPY APPLICATORBest Medical International, Inc.2004-11-03JAQ
K904933000VARIOUS AFTERLOADING APPLICATORSBest Assoc. Corp.1991-01-04IWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841365118593PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841365118593008413651185938413651185930841365118593

GMDN Terms#

Term, Definition table
TermDefinition
Breast brachytherapy system applicator, remote-afterloadingA sterile, remote-afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the breast. It is typically designed for temporary implantation within the breast and serves as a guide for computer-controlled placement and removal of single or multiple radioactive sources. Included are various types of applicators such as hollow needles, tubes, or catheters, and their associated components. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
086352655
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841365121579Best Medical International1634-35-12026-05-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816389028081MAASTRO Rectal Applicator Set, ΓΈ 26 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-06-02
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
00850014612061SIR-Spheres V-VialSirtex Medical Inc.IWJ2021-07-15
00850014612054SIR-Spheres Delivery SetSirtex Medical Inc.IWJ2021-07-14
00850014612092SIR-Spheres Accessories PackSirtex Medical Inc.IWJ2021-07-14
00850014612023SIROS Delivery SetSirtex Medical Inc.IWJ2021-01-05
08717213014305NANucletron B.V.JAQ2019-02-02
08717213008472Shielded Cylindrical ApplicatorNucletron B.V.JAQ2018-07-11
08717213008892NANucletron B.V.JAQ2018-07-11
08717213008908NANucletron B.V.JAQ2018-07-11
08717213008915NANucletron B.V.JAQ2018-07-11
08717213009578Miami Vaginal ApplicatorNucletron B.V.JAQ2018-07-11
08717213009585Miami Vaginal ApplicatorNucletron B.V.JAQ2018-07-11
08717213009646Miami Vaginal ApplicatorNucletron B.V.JAQ2018-07-11
08717213007772Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213007796Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06