SINC

Primary DI
00850025525220
Brand
SINC
Company
REFLOW MEDICAL, INC.
Model
SINC35135US
Published
2024-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233350000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233350000SINC Support CatheterReflow Medical, Inc.2024-02-08DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850025525220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850025525220008500255252208500255252200850025525220

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Working Length135Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
962545294
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856492005692coraForceFRC14150US2020-12-18
00856492005708coraForceFRC14135US2020-12-18
00856492005715coraFlexFLX14135US2020-12-18
00856492005722coraFlexFLX14150US2020-12-18
00856492005142WINGMAN14WGM14150USWGM14150US2016-09-23
00856492005159WINGMAN14WGM14135USWGM14135US2016-09-23
00856492005166WINGMAN35WGM35135USWGM35135US2016-09-23
00856492005173WINGMAN35WGM35090USWGM35090US2016-09-23
00856492005180WINGMAN35WGM35065USWGM35065US2016-09-23
00856492005197WINGMAN14WGM14065USWGM14065US2016-09-23
00856492005234WINGMAN18WGM18090USWGM18090US2016-09-23
00856492005241WINGMAN18WGM18135USWGM18135US2016-09-23
00856492005258WINGMAN18WGM18150USWGM18150US2016-09-23
00856492005296WINGMAN14CWMC14090US2017-09-20
00856492005302WINGMAN14CWMC14135US2017-09-20
00856492005319WINGMAN14CWMC14150US2017-09-20
00850025525169Spur Peripheral Retrievable Stent SystemBSPUR365135US2025-06-06
00850025525176Spur Peripheral Retrievable Stent SystemBSPUR460135US2025-06-06
00850025525213SINCSINC35090US2024-02-19
00850025525022Spex LPSLP35135US2021-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327623338AXS LiftStryker CorporationDQY2025-03-04
07613327623376AXS LiftStryker CorporationDQY2025-03-04
07613327417203AXS Catalyst 7Stryker CorporationDQY2019-05-13
07613327417227AXS Catalyst 7Stryker CorporationDQY2019-05-13
07613327313888DAC 038Stryker CorporationDQY2016-09-21
07613327313901DAC 057Stryker CorporationDQY2016-09-21
07613327313932DAC 070Stryker CorporationDQY2016-09-21
07613327313949DAC 057Stryker CorporationDQY2016-09-21
08033477054322Pacific™ PlusMEDTRONIC, INC.DQY2016-06-26
08033477054360Pacific™ PlusMEDTRONIC, INC.DQY2016-06-26
08033477054384Pacific™ PlusMEDTRONIC, INC.DQY2016-06-26
08033477054391Pacific™ PlusMEDTRONIC, INC.DQY2016-06-26
08033477054407Pacific™ PlusMEDTRONIC, INC.DQY2016-06-26
08033477054421Pacific™ PlusMEDTRONIC, INC.DQY2016-06-26
08033477054438Pacific™ PlusMEDTRONIC, INC.DQY2016-06-26
08033477048772REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048802REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048833REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048864REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048888REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048925REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048956REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048987REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477049014REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477049045REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477049069REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477049076REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477049106REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477049137REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477049168REEF HPMEDTRONIC, INC.DQY2016-06-19