FDA.reportPublic FDA data

GLIDEWIRE

Primary DI
34987350755910
Brand
GLIDEWIRE
Company
TERUMO CORPORATION
Model
EWSS4535
Catalog number
RF*PS35453E
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
34987350755910PackageGS15In Commercial Distribution
54987350755914PackageGS15In Commercial Distribution
04987350755919PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3498735075591034987350755910
5498735075591454987350755914
04987350755919049873507559194987350755919

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 Diameter0.89Millimeter

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
04987350740601GLIDEWIRE GT-RGT*GW1618AGT*GW1618A2026-02-06
04987350740625GLIDEWIRE GT-RGT*GA1818AGT*GA1818A2026-02-06
04987350740649GLIDEWIRE GT-RGT*GA1822AGT*GA1822A2026-02-06
54987350740668GLIDEWIRE GT-RGT*GE1818AGT*GE1818A2026-02-06
04987350740687GLIDEWIRE GT-RGT*GE1822AGT*GE1822A2026-02-06
54987350740699GLIDEWIRE GT-RGT*GW1818AGT*GW1818A2026-02-06
04987350740700GLIDEWIRE GT-RGT*GW1822AGT*GW1822A2026-02-06
04987350745422GLIDEWIRE GT-RGT*GW1622AGT*GW1622A2026-02-06
04987350744487DUALVIEWTU-DSS01CTU*DV01U2026-01-21
54953170465050VISIGLIDEG-240-2527AN36222312025-07-14
54953170465067VISIGLIDEG-240-2545AN36224312025-07-14
54953170465074VISIGLIDEG-240-3527AN36226312025-07-14
54953170465081VISIGLIDEG-240-3545AN36228312025-07-14
54953170465098VISIGLIDEG-240-2527SN36221312025-07-14
54953170465104VISIGLIDEG-240-2545SN36223312025-07-14
54953170465111VISIGLIDEG-240-3527SN36225312025-07-14
54953170465128VISIGLIDEG-240-3545SN36227312025-07-14
54953170465135VISIGLIDE2G-260-2527AN53677312025-07-14
54953170465142VISIGLIDE2G-260-2545AN53681312025-07-14
54953170465159VISIGLIDE2G-260-3527AN53679312025-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262494460616N/ADoppkon GmbH & Co. KGOCY2025-09-12
04262494460623N/ADoppkon GmbH & Co. KGOCY2025-09-12
04262494460630N/ADoppkon GmbH & Co. KGOCY2025-09-12
04262494460647N/ADoppkon GmbH & Co. KGOCY2025-09-12
04262494462528N/ADoppkon GmbH & Co. KGOCY2025-09-12
04262494463969N/ADoppkon GmbH & Co. KGOCY2025-09-12
54953170465050VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465067VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465074VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465081VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465098VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465104VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465111VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465128VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465135VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465142VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465159VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465166VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465173VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465180VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465197VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465203VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
05708932767781SopranoColoplast A/SOCY2025-03-26
16932503510131Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-11-01
16932503510148Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-11-01
16932503510155Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-11-01
16932503510162Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-11-01
16976055232974Zebra Guidewire for Urinary TractSHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.OCY2024-04-24
16976055232981Zebra Guidewire for Urinary TractSHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.OCY2024-04-24
16976055232998Zebra Guidewire for Urinary TractSHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.OCY2024-04-24