FDA.reportPublic FDA data

Wallstent

Primary DI
08714729203070
Brand
Wallstent
Company
LAKE REGION MEDICAL LIMITED
Model
H965180011
Catalog number
H965180011
Device description
"WALLSTENT SS guidewire .035"" B/5"
Published
2016-11-06
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
OCYEndoscopic Guidewire, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCYEndoscopic Guidewire, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729203063PackageGS15In Commercial Distribution
08714729203070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729203063087147292030638714729203063
08714729203070087147292030708714729203070

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose non-vascular guidewireA non-dedicated metal wire designed to position a catheter or similar interventional device (e.g., a dilator or an endoscope) within a lumen of the gastrointestinal (GI) tract, the tracheobronchial tree, and the urinary tract (i.e., not dedicated to either clinical application). Typically, the catheter is advanced over the wire after the wire has been manoeuvred to a treatment site (e.g., site of stent-placement). It is available in a variety of diameters and lengths, may have fluoroscopic markers, or be fitted with an introducer for entering the working channel of the catheter or other interventional device. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0.035Inch

Contacts#

Phone, Email table
PhoneEmail
888-272-1001xx@xx.xx

Regulatory Flags#

DUNS number
988555595
Device count
1
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
08714729172031Starter™ GuidewireM00149135149-1352016-11-06
08714729201298Starter™ GuidewireM00149110149-1102016-11-03
08714729201304Starter™ GuidewireM00149118149-1182016-11-06
08714729201311Starter™ GuidewireM00149132149-1322016-11-06
08714729201328Starter™ GuidewireM00149145149-1452016-11-07
08714729326458Starter™ GuidewireM00149100149-1002016-11-03
08714729326472Starter™ GuidewireM00149103149-1032016-11-03
08714729326489Starter™ GuidewireM00149111149-1112016-11-04
08714729326496Starter™ GuidewireM00149115149-1152016-11-04
08714729326502Starter™ GuidewireM00149116149-1162016-11-04
08714729326519Starter™ GuidewireM00149117149-1172016-11-04
08714729326526Starter™ GuidewireM00149119149-1192016-11-06
08714729326533Starter™ GuidewireM00149120149-1202016-11-06
08714729326540STARTER™ GUIDEM00149121149-1212016-11-06
08714729326557Starter™ GuidewireM00149122149-1222016-11-06
08714729326564Starter™ GuidewireM00149123149-1232016-11-06
08714729326571Starter™ GuidewireM00149130149-1302016-11-06
08714729326588Starter™ GuidewireM00149131149-1312016-11-06
08714729326595Starter™ GuidewireM00149133149-1332016-11-06
08714729326601Starter™ GuidewireM00149134149-1342016-11-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809909421532GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421549GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421556GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421563GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421570GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421587GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421594GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421600GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
04953170465055VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465062VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465079VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465086VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465093VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465109VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465116VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465123VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465130VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465147VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465154VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465161VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465178VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465185VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465192VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465208VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
05708932767774SopranoColoplast A/SOCY2025-03-26
05708932767804SopranoColoplast A/SOCY2025-03-26
06932503510011Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-08-13
06932503510028Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-08-13
06932503510035Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-08-13
06932503510042Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-08-13