FDA.reportPublic FDA data

GLIDEWIRE

Primary DI
54987350756157
Brand
GLIDEWIRE
Company
TERUMO CORPORATION
Model
EWSS4520
Catalog number
RF*PA18453E
Device description
RADIFOCUS GLIDEWIRE
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
34987350756153PackageGS15In Commercial Distribution
54987350756157PackageGS15In Commercial Distribution
04987350756152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3498735075615334987350756153
5498735075615754987350756157
04987350756152049873507561524987350756152

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac/peripheral vascular guidewire, single-useA long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length450Centimeter
Outer Diameter0.51Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile.Keep away from rain. Keep away from sunlight.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)283-7866tmccustomer.admin@terumomedica
+1(800)283-7866tmccustomer.admin@terumomedical.com

Regulatory Flags#

DUNS number
690543319
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987350700025OPTITORQUE40-5011RH*5TIG110A2016-09-09
04987350700049OPTITORQUE40-5012RH*5TIG210A2016-09-09
04987350700063OPTITORQUE40-5021RH*5BL3520A2016-09-09
04987350700087OPTITORQUE40-5022RH*5BL4020A2016-09-09
04987350700100OPTITORQUE40-5030RH*5SP0061A2016-09-09
04987350700124OPTITORQUE40-5031RH*5AP5561A2016-09-09
04987350700148OPTITORQUE40-5040RH*5SL3500A2016-09-09
04987350700162OPTITORQUE40-5041RH*5SL4000A2016-09-09
04987350700186OPTITORQUE40-5042RH*5SL5000A2016-09-09
04987350700209OPTITORQUE40-5043RH*5JR3500A2016-09-09
04987350700223OPTITORQUE40-5044RH*5JR4000A2016-09-09
04987350700247OPTITORQUE40-5045RH*5JR5000A2016-09-09
04987350700261OPTITORQUE40-5050RH*5BPIR00A2016-09-09
04987350700285OPTITORQUE40-5060RH*5SAL100A2016-09-09
04987350700308OPTITORQUE40-5061RH*5SAL200A2016-09-09
04987350700322OPTITORQUE40-6011RH*6TIG110A2016-09-09
04987350700346OPTITORQUE40-6012RH*6TIG210A2016-09-09
04987350700360OPTITORQUE40-6021RH*6BL3520A2016-09-09
04987350700384OPTITORQUE40-6022RH*6BL4020A2016-09-09
04987350700407OPTITORQUE40-6030RH*6SP0061A2016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
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