FDA.reportPublic FDA data

GLIDEWIRE

Primary DI
04987350773432
Brand
GLIDEWIRE
Company
TERUMO CORPORATION
Model
GR3810
Catalog number
RF*GB38153A
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
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQXWIRE, GUIDE, CATHETER
GCJLaparoscope, general & plastic surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34987350773433PackageGS15In Commercial Distribution
54987350773437PackageGS15In Commercial Distribution
04987350773432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3498735077343334987350773433
5498735077343754987350773437
04987350773432049873507734324987350773432

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
Device Size Text, specify0
Length150Centimeter
Outer Diameter0.97Millimeter

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
690543319
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987350739124CAPIOXCX*FX05WACX*FX05WA2021-07-06
04987350739100CAPIOXCX*FX05EACX*FX05EA2021-07-01
04987350781710CAPIOX®FXCX*FX05E2015-09-15
04987350781734CAPIOX®FXCX*FX05W2015-09-15
04987350383075HEARTRAIL40-6370GC-U6IL350N2016-09-09
04987350383099HEARTRAIL40-6371GC-U6IL350A2016-09-09
04987350383112HEARTRAIL40-6372GC-U6IL3G0N2016-09-09
04987350383136HEARTRAIL40-6373GC-U6IL400N2016-09-09
04987350383150HEARTRAIL40-6374GC-U6IL400A2016-09-09
04987350383174HEARTRAIL40-6375GC-U6IL450N2016-09-09
04987350383198HEARTRAIL40-6376GC-U6IL450A2016-09-09
04987350383235HEARTRAIL40-6380GC-U6IR100N2016-09-09
04987350383259HEARTRAIL40-6381GC-U6IR150N2016-09-09
04987350383273HEARTRAIL40-6382GC-U6IR200N2016-09-09
04987350423795HEARTRAIL40-6383GC-U6IR100A2016-09-09
04987350423818HEARTRAIL40-6385GC-U6IR200A2016-09-09
04987350423832HEARTRAIL40-6377GC-U6IL3G0A2016-09-09
04987350423856HEARTRAIL40-6384GC-U6IR150A2016-09-09
04987350423870HEARTRAIL40-6311GC-U6TG400N2016-09-09
04987350703163FINECROSS35-1430NC*F863A2016-09-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B382SD13768330Surgical DirectSurgical Direct, Inc.GCJ2026-09-30
B382SD9156321100Surgical DirectSurgical Direct, Inc.GCJ2026-09-30
B382SD49195170Surgical DirectSurgical Direct, Inc.GCJ2026-09-29
B382SD9039841050Surgical DirectSurgical Direct, Inc.GCJ2026-09-29
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00724995268343Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268350Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
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00724995268398Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268404Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268411Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268428Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268435Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268442Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25