FDA.reportPublic FDA data

SureCross

Primary DI
00884450423110
Brand
SureCross
Company
Merit Medical Systems, Inc.
Model
D
Catalog number
SC1465
Published
2026-09-22
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

Product Codes#

Code, Name table
CodeName
DQYCatheter, percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450423117PackageGS15In Commercial Distribution
20884450423114PackageGS15In Commercial Distribution
00884450423110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445042311710884450423117
2088445042311420884450423114
00884450423110008844504231108844504231100884450423110

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Regulatory Flags#

DUNS number
184763290
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
false
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
00884450099346Merit Medical®Initial ReleaseK05-02879B2026-11-05
00884450163351Merit Medical®Initial ReleaseK09-11704C2026-11-05
00884450420034Merit Medical®Initial ReleaseK09-14260A2026-11-05
00884450420263Merit Medical®Initial ReleaseK09-11289A2026-11-05
00884450431535Merit Medical®Initial ReleaseK12-04729B2026-11-05
00884450436530Merit Medical®Initial ReleaseK09-05978D2026-11-05
00884450436974Merit Medical®Initial ReleaseK09-09344D2026-11-05
00884450508763Merit Medical®Initial ReleaseK09-13864D2026-11-05
00884450163917Merit Medical®Initial ReleaseK09-12030B2026-11-04
00884450431443Merit Medical®Initial ReleaseK08-03296A2026-11-04
00884450456385ReSolve®GRBDC-14-0382026-11-04
00884450503829Merit Medical®Initial ReleaseK09-13310D2026-11-04
00884450794739DuraMax®AH7871030290152026-11-03
00884450838228Prelude Roadster™APG8F45S2026-11-03
00884450839355Prelude Roadster™APG7F90SX2026-11-04
10884450708467Prelude®FPSI-7F-11-038-18G2026-11-03
00884450148174Merit Medical®Initial ReleaseK09-09012A2026-10-31
00884450428061Merit Medical®Initial ReleaseK10-01518B2026-10-31
00884450436936Merit Medical®Initial ReleaseK12-07972A2026-10-30
00884450499191Merit MAK™GMAK401N-E2026-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0086001552777687 NeuGlide+ CatheterPIRAEUS MEDICAL INC.DQY2026-10-29
07613327682427Excelsior ReachStryker CorporationDQY2026-10-29
07613327682434Excelsior ReachStryker CorporationDQY2026-10-29
07613327682441Excelsior ReachStryker CorporationDQY2026-10-29
07613327682458Excelsior ReachStryker CorporationDQY2026-10-29
07613327682465Excelsior ReachStryker CorporationDQY2026-10-29
07613327682496Excelsior ReachStryker CorporationDQY2026-10-29
07613327682526Excelsior ReachStryker CorporationDQY2026-10-29
07613327682571Excelsior ReachStryker CorporationDQY2026-10-29
00802526625008ACUITY™BOSTON SCIENTIFIC CORPORATIONDQY2026-10-15
0086001552773870 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
0086001552774570 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
00810068568998Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00840303713104Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00884450416723SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450422755SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450427170SureCrossMerit Medical Systems, Inc.DQY2026-09-22
10886704074892ENVOYCerenovus, Inc.DQY2026-09-19
08718122024218Climber Guiding CatheterPendraCare International B.V.DQY2026-05-19
00857545008394ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008400ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008431ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008448ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
00884450838167Ventrax™Merit Medical Systems, Inc.DQY2026-01-13
00884450838174Ventrax™Merit Medical Systems, Inc.DQY2026-01-13
10841156111250GUIDELINERTELEFLEX INCORPORATEDDQY2025-07-14