FDA.reportPublic FDA data

ARROW

Primary DI
10801902122503
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN036227
Catalog number
AW-04435
Device description
Marked Spring-Wire Guide with Arrow Advancer
Published
2016-09-16
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
MPBCatheter, hemodialysis, non-implanted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPBCatheter, Hemodialysis, Non-ImplantedGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30801902122507PackageGS125Not in Commercial Distribution
40801902122504PackageGS11Not in Commercial Distribution
10801902122503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3080190212250730801902122507
4080190212250440801902122504
1080190212250310801902122503

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular guidewire, manualA long, thin wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14026704927910PILLINGIPN0079065068002026-07-08
10801902226171ARROWPR-45552-BASPR-45552-BAS2026-07-06
10841156112035LANGSTONIPN93901955402026-06-26
10801902218732ARROWIPN928981CS-15853-E2026-06-24
10801902221725ARROWIPN930533EC-055002026-06-24
14026704664983HUDSON RCIIPN039676158002026-06-24
14026704664990HUDSON RCIIPN039677158022026-06-24
14026704665003HUDSON RCIIPN039678158042026-06-24
14026704665027HUDSON RCIIPN039680158082026-06-24
14026704665034HUDSON RCIIPN039681158102026-06-24
14026704665164HUDSON RCIIPN03969412712026-06-24
14026704665171HUDSON RCIIPN03969512722026-06-24
14026704665195HUDSON RCIIPN03969712742026-06-24
14026704665201HUDSON RCIIPN03969812752026-06-24
14026704924254PLEUR-EVACIPN929357PE104-082026-06-24
15060112315029LMA AIRWAY MANAGEMENTIPN0487781280302026-06-24
15060112315036LMA AIRWAY MANAGEMENTIPN0487801280402026-06-24
15060112315043LMA AIRWAY MANAGEMENTIPN0487821280502026-06-24
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902225518ARROWTELEFLEX INCORPORATEDMPB2026-03-11
10801902223088ARROWTELEFLEX INCORPORATEDMPB2025-10-01
10801902223095ARROWTELEFLEX INCORPORATEDMPB2025-10-01
10801902222258ARROWTELEFLEX INCORPORATEDMPB2025-06-12
10801902222265ARROWTELEFLEX INCORPORATEDMPB2025-06-12
10801902222272ARROWTELEFLEX INCORPORATEDMPB2025-06-12
10801902222296ARROWTELEFLEX INCORPORATEDMPB2025-06-12
10801902222302ARROWTELEFLEX INCORPORATEDMPB2025-06-12
10801902222319ARROWTELEFLEX INCORPORATEDMPB2025-06-12
10801902222241ARROWTELEFLEX INCORPORATEDMPB2025-06-10
10801902221923ARROWTELEFLEX INCORPORATEDMPB2025-05-13
10801902222487ARROWTELEFLEX INCORPORATEDMPB2025-04-04
10801902222494ARROWTELEFLEX INCORPORATEDMPB2025-04-04
10801902202410ARROWTELEFLEX INCORPORATEDMPB2024-09-06
10801902202427ARROWTELEFLEX INCORPORATEDMPB2024-09-06
10853072007173Dual Lumen Extended Length Catheter (15cm)Nuwellis Inc.MPB2024-02-20
10853072007210Dual Lumen Extended Length Catheter (11cm) and GALT Insertion KitNuwellis Inc.MPB2024-02-20
10853072007234Dual Lumen Extended Length Catheter (15cm) and GALT Insertion KitNuwellis Inc.MPB2024-02-20
10801902213638ARROWTELEFLEX INCORPORATEDMPB2023-05-03
10801902213652ARROWTELEFLEX INCORPORATEDMPB2023-05-03
10801902213676ARROWTELEFLEX INCORPORATEDMPB2023-05-03
10801902213683ARROWTELEFLEX INCORPORATEDMPB2023-05-03
10801902213690ARROWTELEFLEX INCORPORATEDMPB2023-05-03
10801902213706ARROWTELEFLEX INCORPORATEDMPB2023-05-03
10801902213713ARROWTELEFLEX INCORPORATEDMPB2023-05-03
10801902213478ARROWTELEFLEX INCORPORATEDMPB2023-04-27
10801902213492ARROWTELEFLEX INCORPORATEDMPB2023-04-27
10801902213515ARROWTELEFLEX INCORPORATEDMPB2023-04-27
10801902213539ARROWTELEFLEX INCORPORATEDMPB2023-04-27
10801902213546ARROWTELEFLEX INCORPORATEDMPB2023-04-27