FDA.report

GLIDEWIRE

Primary DI
54987350778593
Brand
GLIDEWIRE
Company
TERUMO CORPORATION
Model
GR3521
Catalog number
RF*GE35185A
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

Related Records

Product Codes

CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34987350778599PackageGS15In Commercial Distribution
54987350778593PackageGS15In Commercial Distribution
04987350778598PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3498735077859934987350778599
5498735077859354987350778593
04987350778598049873507785984987350778598

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0
Length180Centimeter
Outer Diameter0.89Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Fragile.Keep away from rain. Keep away from sunlight.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)283-7866tmccustomer.admin@terumomedica

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

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54953170465128VISIGLIDEG-240-3545SN36227312025-07-14
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