FDA.reportPublic FDA data

Argyle

Primary DI
10884521024335
Brand
Argyle
Company
Mozarc Medical US LLC
Model
8815544013
Device description
Chronic Catheter Accessory,Oval Pull Apart Introducer Set
Published
2016-09-24
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

Contact Domains#

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
20884521024332PackageGS15In Commercial Distribution
10884521024335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452102433220884521024332
1088452102433510884521024335

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, implantableA collection of devices which includes an implantable device(s) intended to provide percutaneous, peripheral, arterial access to enable repeated introduction of a catheter (not included) into the vascular system over an extended period (e.g., months) without vascular wound closure. It includes an implantable non-steerable introducer sheath, an inner obturator/occluder, and typically an additional access device(s) [e.g., haemostatic valve, stylet]. The introducer sheath is typically anastomosed to the blood vessel and externalised via a subcutaneous tunnel; the occluder is intended to plug the introducer sheath between uses. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+39053529111RegulatoryOperations@mozarcmedical.com

Regulatory Flags#

DUNS number
118997146
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521004801MAHURKAR88137930092015-10-22
10884521004832MAHURKAR88137930132015-10-22
10884521004887MAHURKAR88138160092015-10-22
10884521004894MAHURKAR88138170052015-10-22
10884521004931MAHURKAR88156680072016-10-13
10884521005006MAHURKAR88171430052015-10-22
10884521005020MAHURKAR88171460012015-10-22
10884521005037MAHURKAR88171460072015-10-22
10884521005150MAHURKAR88304150012015-10-22
10884521005174MAHURKAR88304150032015-10-22
10884521005303MAHURKAR88325390012015-10-22
10884521005341MAHURKAR88325390062015-10-22
20884521004877MAHURKAR88138160052015-10-22
20884521005317MAHURKAR88325390022015-10-22
10884521832930MAHURKAR88156680212022-11-03
10884521832985MAHURKAR88316630212022-11-03
10884521057098MAHURKAR88156680212015-10-22
10884521057234MAHURKAR88316630212015-10-22
10884521811164Ritus88155440102026-04-20
10884521811270Ritus88108050012026-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450438791Prelude® Short SheathMerit Medical Systems, Inc.DYB2026-10-06
10884450119751Prelude EASE™Merit Medical Systems, Inc.DYB2026-09-29
10884450439163Prelude IDeal™Merit Medical Systems, Inc.DYB2026-09-29
10884450439187Prelude IDeal™Merit Medical Systems, Inc.DYB2026-09-29
10801902226188ARROWTELEFLEX INCORPORATEDDYB2026-09-28
10801902228700ARROWTELEFLEX INCORPORATEDDYB2026-09-22
10884450489809Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489816Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489823Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489830Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489847Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489854Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489861Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489878Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489885Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489892Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489908Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489915Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489922Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489939Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489946Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489953Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489960Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489977Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489984Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450495091Hydrophilic Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450510602Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10884450510640Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10884450510664Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10801902227109ARROWTELEFLEX INCORPORATEDDYB2026-09-03