FDA.reportPublic FDA data

PreludeSYNC™

Primary DI
10884450445201
Brand
PreludeSYNC™
Company
Merit Medical Systems, Inc.
Model
10884450445201
Published
2019-10-03
Public version status
Update
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
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
10884450445201PrimaryGS10
00884450445204Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445044520110884450445201
00884450445204008844504452048844504452040884450445204

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.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450735916Merit Advance®AAD18N91W-E2026-10-19
10884450735906Merit Advance®AAD18N91W2026-10-19
10884450735920Merit Advance®AAD18T51W2026-10-19
10884450735944Merit Advance®AAD18T51WS2026-10-19
10884450735968Merit Advance®AAD18T71W2026-10-19
10884450735975Merit Advance®AAD18T71WC2026-10-19
10884450735999Merit Advance®AAD18T71W-E2026-10-19
10884450736033Merit Advance®AAD18T71WS2026-10-19
10884450736057Merit Advance®BAD18T71WT2026-10-19
10884450736071Merit Advance®AAD19U41W2026-10-19
10884450736118Merit Advance®AAD19U51W2026-10-19
10884450736132Merit Advance®AAD19U71W2026-10-19
10884450736149Merit Advance®AAD19U71WC2026-10-19
10884450736187Merit Advance®AAD19U71WS2026-10-19
10884450736224Merit Advance®AAD20T41W2026-10-19
10884450736262Merit Advance®AAD20T71W2026-10-19
10884450736309Merit Advance®AAD21T21W2026-10-19
10884450736361Merit Advance®AAD21T41WC2026-10-19
10884450736385Merit Advance®AAD21T41W-E2026-10-19
10884450736439Merit Advance®AAD21T71W2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435226MillenniumAvalign Technologies, Inc.DXC2026-10-19
00190776436230MillenniumAvalign Technologies, Inc.DXC2026-10-08
00190776436247MillenniumAvalign Technologies, Inc.DXC2026-10-08
M68931200070CrOCSafeguard US Operating, LLCDXC2026-10-08
00190776434267MillenniumAvalign Technologies, Inc.DXC2026-10-06
00190776434335MillenniumAvalign Technologies, Inc.DXC2026-10-06
00190776434366MillenniumAvalign Technologies, Inc.DXC2026-10-06
00190776434373MillenniumAvalign Technologies, Inc.DXC2026-10-06
00190776433314MillenniumAvalign Technologies, Inc.DXC2026-10-05
00810220800577Adler Instrument CompanyAdler, Inc.DXC2026-09-30
00846159036411SCANLAN® ClampSCANLAN INTERNATIONAL INCDXC2026-09-21
00846159036428SCANLAN® ClampSCANLAN INTERNATIONAL INCDXC2026-09-21
00190776424107MillenniumAvalign Technologies, Inc.DXC2026-08-27
00190776423889MillenniumAvalign Technologies, Inc.DXC2026-08-26
00190776420345MillenniumAvalign Technologies, Inc.DXC2026-08-25
00190776419080MillenniumAvalign Technologies, Inc.DXC2026-08-23
00190776419127MillenniumAvalign Technologies, Inc.DXC2026-08-23
00190776417154MillenniumAvalign Technologies, Inc.DXC2026-08-19
00190776411527MillenniumAvalign Technologies, Inc.DXC2026-08-07
00190776408633MillenniumAvalign Technologies, Inc.DXC2026-08-03
00190776422318MillenniumAvalign Technologies, Inc.DXC2026-07-31
00885403523000FOGARTY SOFTJAWBecton, Dickinson And CompanyDXC2026-07-30
00885403523161FOGARTY HYDRAJAWBecton, Dickinson And CompanyDXC2026-07-30
00885403523253FOGARTY SOFTJAWBecton, Dickinson And CompanyDXC2026-07-30
00885403523277FOGARTY SOFTJAWBecton, Dickinson And CompanyDXC2026-07-30
10841156102012D-STATTELEFLEX INCORPORATEDDXC2026-07-30
00190776404178MillenniumAvalign Technologies, Inc.DXC2026-07-24
00190776404185MillenniumAvalign Technologies, Inc.DXC2026-07-24
00190776400248MillenniumAvalign Technologies, Inc.DXC2026-07-21
00190776403287MillenniumAvalign Technologies, Inc.DXC2026-07-21