FDA.reportPublic FDA data

Hydrophilic Prelude SNAP™

Primary DI
10884450495565
Brand
Hydrophilic Prelude SNAP™
Company
Merit Medical
Model
10884450495565
Catalog number
PLSH-1009.5/A
Published
2021-11-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450495565PrimaryGS10
00884450495568Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445049556510884450495565
00884450495568008844504955688844504955680884450495568

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Device Sizes#

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

Regulatory Flags#

DUNS number
065673912
Device count
5
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884450313654Prelude Prestige™10884450313654PLPS-25162020-07-16
10884450313739Prelude Prestige™10884450313739PLPS-10082021-04-09
10884450313760Prelude Prestige™10884450313760PLPS-25102020-06-02
10884450313791Prelude Prestige™10884450313791PLPS-25082020-06-02
10884450313807Prelude Prestige™10884450313807PLPS-10102021-04-09
10884450313821Prelude Prestige™10884450313821PLPS-25072020-07-16
10884450313838Prelude Prestige™10884450313838PLPS-10112021-04-09
10884450313852Prelude Prestige™10884450313852PLPS-10122021-04-09
10884450313869Prelude Prestige™10884450313869PLPS-25052020-07-16
00884450161944SafeSheath CSG00884450161944CSG-90-092017-03-14
00884450161951SafeSheath CSG00884450161951FCL-069-002017-02-20
00884450161975SafeSheath CSG00884450161975FCL-069-022018-01-15
00884450161982SafeSheath CSG00884450161982FCL-069-032017-05-24
00884450161999SafeSheath CSG00884450161999FCL-070-002017-05-08
00884450162002SafeSheath CSG00884450162002FCL-070-012017-10-16
00884450162033SafeSheath CSG00884450162033FCL-083-002017-02-15
00884450162040SafeSheath CSG00884450162040FCL-083-012017-02-15
00884450162057SafeSheath CSG00884450162057FCL-083-022017-02-15
00884450162064SafeSheath CSG00884450162064FCL-083-032017-02-15
00884450162101SafeSheath CSG00884450162101FCL-090-002017-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850064198676Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
00850064198683Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
10884450114008Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-09
10884450119799Prelude EASE™Merit Medical Systems, Inc.DYB2026-06-09
10884450114855Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-08
00850084947001Genie MAXCULTIV8 1, LLCDYB2026-05-29
G440VIZ1750MultiflexVizaramed, Inc.DYB2026-04-09
04251244502768Catapult Guide SheathContract Medical International GmbHDYB2024-08-19
04251244502775Catapult Guide SheathContract Medical International GmbHDYB2024-08-19
04251244502782Catapult Guide SheathContract Medical International GmbHDYB2024-08-19
04251244501983Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244501990Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502003Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502010Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502027Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502034Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502041Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502058Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502065Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502072Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502089Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502096Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502102Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502119Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502126Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502133Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502140Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502157Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502164Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502171Catapult Guide SheathContract Medical International GmbHDYB2023-09-01