FDA.reportPublic FDA data

Best Medical International

Primary DI
00841365112539
Brand
Best Medical International
Company
BEST MEDICAL INTERNATIONAL, INC.
Model
10113-C
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
IWISource, Isotope, Sealed, Gold, Titanium, Platinum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWISource, Isotope, Sealed, Gold, Titanium, PlatinumRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K912170000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K912170000RADIOACTIVE IODINE-125 SOURCESBest Industries1991-08-09IWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841365112539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841365112539008413651125398413651125390841365112539

GMDN Terms#

Term, Definition table
TermDefinition
Manual brachytherapy source, permanent implantA device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope and intended to be permanently implanted into the body in order to deliver curative or palliative radiotherapy treatments. It is typically placed in the body by means of an applicator using either fluoroscopic or endoscopic guidance. Manually implanted sources intended for permanent implantation are designed to be histocompatible. It may take the form of, e.g., microspheres, spheres, stents, seeds or wires selected for producing low energy photons, beta or alpha particles.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
086352655
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration 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
00841365106965Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWI2015-09-23
00841365106972Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWI2015-09-23
00841365106989Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWI2015-09-23
00841365106996Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWI2015-09-23
00841365107009Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWI2015-09-23
00841365107016Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWI2015-09-23
00841365107023Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWI2015-09-23
00841365107030Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWI2015-09-23
00841365107047Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWI2015-09-23
00841365107054Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWI2015-09-23
00841365107061Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWI2015-09-23
00841365107078Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWI2015-09-23
00841365107085Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWI2015-09-23
00841365112560Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWI2015-09-23