FDA.reportPublic FDA data

PreludeSYNC EVO™

Primary DI
20884450462946
Brand
PreludeSYNC EVO™
Company
Merit Medical Systems, Inc.
Model
10884450462949
Catalog number
SRB24LBAC/A
Published
2021-01-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DXCCLAMP, VASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180723000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180723000PreludeSYNC DISTAL Radial Compression SystemMerit Medical Systems, Inc.2018-04-17DXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884450462946PackageGS14In Commercial Distribution
10884450462949PrimaryGS10
00884450462942Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088445046294620884450462946
1088445046294910884450462949
00884450462942008844504629428844504629420884450462942

GMDN Terms#

Term, Definition table
TermDefinition
Vascular compressor, externalA thin, gently curved sheet of radiolucent plastic used for external compression of the internal spermatic vein to prevent distal flow of a sclerosing agent. The device is also used in the compression of additional veins, bypass grafts, and fistulas during angiographic procedures. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
5
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
00884450029695Merit Medical®Initial ReleaseK08-02207A2026-07-24
00884450383865Merit Medical®Initial ReleaseK10-01245L2026-07-25
00884450419922SureCrossDSC181352026-07-24
00884450428320Merit Medical®Initial ReleaseK09-10593C2026-07-24
00884450470831Merit Medical®Initial ReleaseK09-12157A2026-07-24
00884450484203Merit Medical®Initial ReleaseK09-144012026-07-24
00884450485569Merit Medical®Initial ReleaseK12T-127302026-07-24
00884450486214Merit Medical®Initial ReleaseK12T-12593A2026-07-24
00884450486955Merit Medical®Initial ReleaseK02-016512026-07-25
00884450545010Aspira®Initial Release49925242026-07-25
00884450545034Aspira®Initial Release4992524B2026-07-25
00884450793817BioFlo DuraMax®AH9651030380112026-07-25
00884450846148Merit Medical®Initial ReleaseK09-14237A2026-07-25
00884450433812Merit Medical®Initial ReleaseK08-02803A2026-07-23
00884450485163Merit Medical®Initial ReleaseK12T-11888B2026-07-23
00884450376546Merit Medical®Initial ReleaseK09-05229L2026-07-22
00884450431764Merit Medical®Initial ReleaseK10-04836A2026-07-22
00884450488751Merit Medical®Initial ReleaseK09-144102026-07-22
00884450492888Merit Medical®Initial ReleaseK01-08008A2026-07-22
00884450499276Merit Medical®Initial ReleaseK09-13679B2026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776404178MillenniumAvalign Technologies, Inc.DXC2026-07-24
00190776404185MillenniumAvalign Technologies, Inc.DXC2026-07-24
00190776400248MillenniumAvalign Technologies, Inc.DXC2026-07-21
00190776403287MillenniumAvalign Technologies, Inc.DXC2026-07-21
00190776403294MillenniumAvalign Technologies, Inc.DXC2026-07-21
00810220800461Adler Instrument CompanyAdler, Inc.DXC2026-07-17
00190776397180MillenniumAvalign Technologies, Inc.DXC2026-07-16
00190776395605MillenniumAvalign Technologies, Inc.DXC2026-07-14
00190776395698MillenniumAvalign Technologies, Inc.DXC2026-07-14
00190776395711MillenniumAvalign Technologies, Inc.DXC2026-07-14
00192896123557Debakey Neonatal ClampSONTEC INSTRUMENTS, INC.DXC2026-07-10
00846159036152SCANLAN® Bulldog ClampSCANLAN INTERNATIONAL INCDXC2026-06-23
00846159036404SCANLAN® Bulldog ClampSCANLAN INTERNATIONAL INCDXC2026-06-09
00810220800348Adler Instrument CompanyAdler, Inc.DXC2026-06-02
10197344138890NAMICMEDLINE INDUSTRIES, INC.DXC2026-03-16
08022057015884DeTACH Aortic Cross Clamp Head-LargeCORCYM SRLDXC2026-02-03
08022057015907DeTACH Aortic Cross Clamp Head-SmallCORCYM SRLDXC2026-02-03
10193489727173Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DXC2022-08-04
10195594150808CARDINAL HEALTHCardinal Health 200, LLCDXC2021-07-09
20884521152134CovidienCardinal Health, Inc.DXC2016-09-24
M20630300D-Stat® Clamp topical hemostat accessoryVascular Solutions, Inc.DXC2016-09-15
M20635240Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635270Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635290Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635370Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
10381780142935Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14
10381780142942Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14
10381780142959Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14
10381780142966Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14
10381780142973Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14