FDA.report

GLIDEWIRE

Primary DI
54987350754757
Brand
GLIDEWIRE
Company
TERUMO CORPORATION
Model
EWR4035
Catalog number
RF*GS35263E
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

Contact Domains

Product Codes

CodeName
OCYEndoscopic guidewire, gastroenterology-urology

Product Code Classifications

CodeDeviceSpecialtyClass
OCYEndoscopic Guidewire, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34987350754753PackageGS15In Commercial Distribution
54987350754757PackageGS15In Commercial Distribution
04987350754752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3498735075475334987350754753
5498735075475754987350754757
04987350754752049873507547524987350754752

GMDN Terms

TermDefinition
Gastro-urological guidewire, single-useA sterile metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length260Centimeter
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
+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

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