FDA.reportPublic FDA data

Sinton Medical Products

Primary DI
06938327900649
Brand
Sinton Medical Products
Company
Shenzhen Boon Medical Supply Co., Ltd.
Model
200104-B
Catalog number
HS-NMD50T
Device description
"2-50 mL Syringes 1-Large Spike & 1-Small Spike1-96"" T Coiled Tubing with Check Valve"
Published
2017-09-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXTInjector And Syringe, Angiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXTInjector And Syringe, AngiographicCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151960000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151960000Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd.2016-01-07DXT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26938327900643PackageGS150Not in Commercial Distribution
26938327900649PackageGS150In Commercial Distribution
06938327900649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2693832790064326938327900643
2693832790064926938327900649
06938327900649069383279006496938327900649

GMDN Terms#

Term, Definition table
TermDefinition
Angiographic syringeA sterile, manually-operated device consisting of a barrel (cylinder) with plunger intended to be used for the administration of a contrast medium into the heart, great vessels, and coronary arteries to study the heart and vessels under x-ray photography. It may in addition be intended for introduction of other fluids (e.g., saline). It is not intended to be used with a contrast medium injection system. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(954)380-8873sales@sintonmedicalproducts.com

Regulatory Flags#

DUNS number
529174252
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
06938327909888Sinton Medical Products100103-SHS-DC201S2026-07-20
06938327909895Sinton Medical Products100113-SHS-DCD201S2026-07-20
06938327909901Sinton Medical Products100103-THS-DC201T2026-07-20
06938327909918Sinton Medical Products100113-THS-DCD201T2026-07-20
06938327909215Sinton Medical Products100103-WHS-DC2012026-03-27
06938327901905DeRoyal100113-IDRS-DCD2012025-11-28
26938327901909DeRoyal100113-IDRS-DCD2012025-11-28
06938327909185Sinton Medical Products100108-WHS-NC200 Plus2025-11-17
06938327909192Sinton Medical Products400102-20HT-LY15022025-11-17
06938327909208Sinton Medical Products400102-25HT-LY18022025-11-17
26938327909189Sinton Medical Products100108-WHS-NC200 Plus2025-11-17
16938327909199Sinton Medical Products400102-20HT-LY15022025-11-17
16938327909205Sinton Medical Products400102-25HT-LY18022025-11-17
06938327909666Sinton Medical Products400204-3HT-L2502F2024-10-31
06938327909765Sinton Medical Products700206-2HT-SK500F2021-11-13
06938327909772Sinton Medical Products700207-1HT-SK501F2021-11-13
06938327909789Sinton Medical Products700207-2HT-SK502F2024-01-16
06938327909796Sinton Medical Products700207-2AHT-SK501FC2024-01-16
06938327909802Sinton Medical Products700206-2AHT-SK500F2024-01-16
06938327909819Sinton Medical Products700207-1AHT-SK501FS2024-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06938327909888Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2026-07-20
06938327909895Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2026-07-20
06938327909901Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2026-07-20
06938327909918Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2026-07-20
10841716103657AngioTouch Module (15')ACIST MEDICAL SYSTEMS, INC.DXT2026-06-08
10841716104296ACIST Pro Diagnostic SystemACIST MEDICAL SYSTEMS, INC.DXT2026-06-07
09345390003523MEDRAD® Centargo Patient Line (350 cm)IMAXEON PTY LTDDXT2026-05-06
06938327909215Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2026-03-27
09345390003530MEDRAD® Centargo Patient LineIMAXEON PTY LTDDXT2025-12-10
10193489065824NAMICMEDLINE INDUSTRIES, INC.DXT2025-05-15
10193489066029NAMICMEDLINE INDUSTRIES, INC.DXT2025-05-15
10193489066043NAMICMEDLINE INDUSTRIES, INC.DXT2025-05-15
10193489066081NAMICMEDLINE INDUSTRIES, INC.DXT2025-05-15
09345390002656MEDRAD® Centargo Patient LineIMAXEON PTY LTDDXT2025-03-28
09345390002717MEDRAD® Centargo Replacement SpikeIMAXEON PTY LTDDXT2025-03-28
09345390003097MEDRAD® Centargo Day Set IMAXEON PTY LTDDXT2025-03-28
09345390003349MEDRAD® Centargo CT Injection SystemIMAXEON PTY LTDDXT2025-03-28
10193489065831NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489065916NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489066067NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489066104NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489066142NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489066159NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489065848NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065855NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065886NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065893NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065923NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065930NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065947NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05