FDA.reportPublic FDA data

Best Medical International

Primary DI
00841365106941
Brand
Best Medical International
Company
BEST MEDICAL INTERNATIONAL, INC.
Model
1922
Published
2015-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JAQSystem, Applicator, Radionuclide, Remote-Controlled

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132097000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132097000BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPYBest Medical International, Inc.2013-09-30JAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841365106941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841365106941008413651069418413651069410841365106941

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative/postoperative therapeutic x-ray system balloon applicator kitA sterile collection of devices that is a component of an intraoperative/postoperative therapeutic x-ray system designed for the administration of radiation in certain clinical applications, typically intraoperatively within a resected breast tumour bed. It typically consists of a set of cavity ball gauges used for measurement of the cavity, and a set of graduated size balloon applicators. The required size of applicator is intended to be placed in the tumour cavity after lumpectomy and inflated, and the inner catheter is designed to hold the tube of the x-ray source, stabilized by a probe guard, during radiotherapy treatment. This is a single-use device.

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
00841365121593Best Medical International2370-29.4-12026-08-03
00841365121609Best Medical International2370-29.4-52026-08-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841436125451Classic StepperCIVCO MEDICAL INSTRUMENTS CO., INC.JAQ2026-07-23
00810563022551Needle collector pair for Titanium Fletcher-style applicatorVARIAN MEDICAL SYSTEMS, INC.JAQ2024-11-19
00850645007007AOS Marker SeedsALPHA-OMEGA SERVICES, INC.JAQ2024-07-15
00816389020245Crook Prostate Template for 2.0 mm needlesVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-19
00810563021967Plastic needle MR safe, 2.0 mm diameter x 200 mm length, with mandrinVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00810563021974Plastic needle MR safe, 2.0 mm diameter x 320 mm length, with mandrinVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00810563021981Plastic needle MR safe, 2.0 mm diameter x 320 mm length, blunt tip, with mandrinVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00810563022001Mandrin for 200 mm lengthVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00810563022018Mandrin for 320 mm lengthVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00810563022025Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrinVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00810563021998Mandrin for 113 mm lengthVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00816389022522Mandrin for 200mm length Needle for Plastic Interstitial NeedleVARIAN MEDICAL SYSTEMS, INC.JAQ2021-02-02
00863593000235HDR MRI Lumen MarkerC4 IMAGING, LLCJAQ2018-06-11
08717213043329X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043336X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043343X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043688X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043695X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043701X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043718X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043725X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043732X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043749X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043756X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043763X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213021662X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213028463X-ray CathetersNucletron B.V.JAQ2016-09-25
10816389027296Universal fixation button, radiopaque, pack of 100, non-sterileVARIAN MEDICAL SYSTEMS, INC.JAQ2016-09-23
00816389021747Central clamping mechanismVARIAN MEDICAL SYSTEMS, INC.JAQ2016-09-23
00816389021778Intrauterine probe with stop, 30 degrees angle, length 80mmVARIAN MEDICAL SYSTEMS, INC.JAQ2016-09-23