FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450164624
Brand
Merit Medical®
Company
Merit Medical
Model
00884450164624
Catalog number
MIS-099-00
Published
2017-02-23
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
DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450164621PackageGS15In Commercial Distribution
00884450164624PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445016462110884450164621
00884450164624008844501646248844501646240884450164624

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.

Regulatory Flags#

DUNS number
065673912
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
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
10884450495565Hydrophilic Prelude SNAP™10884450495565PLSH-1009.5/A2021-11-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436674MilleniumAvalign Technologies, Inc.DWS2026-10-20
00190776436704MilleniumAvalign Technologies, Inc.DWS2026-10-20
00190776437657MilleniumAvalign Technologies, Inc.DWS2026-10-20
00190776437770MillenniumAvalign Technologies, Inc.DWS2026-10-20
00190776437794MillenniumAvalign Technologies, Inc.DWS2026-10-20
03661219455073LANDANGERLANDANGERDWS2026-10-19
03661219008224LANDANGERLANDANGERDWS2026-10-12
03661219389811DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219510024DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525486DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525509DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525523DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525547DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525561DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525585DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525608DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525943DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525950DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525967DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525974DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525981DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219527442DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
04058749009897NAFehling Instruments GmbH & Co. KGDWS2026-10-12
04058749125931NAFehling Instruments GmbH & Co. KGDWS2026-10-12
03661219320265DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
03661219438601DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
03661219442943DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
03661219528388DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
00190776434236MillenniumAvalign Technologies, Inc.DWS2026-10-09
00190776436216MillenniumAvalign Technologies, Inc.DWS2026-10-08