FDA.reportPublic FDA data

Sinton Medical Products

Primary DI
26938327909134
Brand
Sinton Medical Products
Company
Shenzhen Boon Medical Supply Co., Ltd.
Model
100122
Catalog number
HS-GCD200
Device description
2-200ml Syringes 2-Fill Straws 1-72" Y Coiled Tubing with Dual Check Valves
Published
2025-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K241109000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241109000Single-use Sterile High-pressure Angiographic Syringes and AccessoriesShenzhen Boon Medical Supply Co., Ltd.2024-08-22DXT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26938327909134PackageGS120In Commercial Distribution
06938327909130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2693832790913426938327909134
06938327909130069383279091306938327909130

GMDN Terms#

Term, Definition table
TermDefinition
Angiography kitA collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06938327909215Sinton Medical Products100103-IHS-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
06938327909826Sinton Medical Products700207-2BHT-SK500FC2024-01-16
06938327909833Sinton Medical Products700206-1AHT-SK200F2024-02-28
06938327909840Sinton Medical Products700207-1CHT-SK501FS2024-10-31
06938327909857Sinton Medical Products700207-2CHT-SK501FC2024-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09345390003523MEDRAD® Centargo Patient Line (350 cm)IMAXEON PTY LTDDXT2026-05-06
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
10193489065954NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065961NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065978NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065985NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065992NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489066005NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489066012NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05