FDA.reportPublic FDA data

GLIDESHEATH SLENDER

Primary DI
04987350718006
Brand
GLIDESHEATH SLENDER
Company
TERUMO CORPORATION
Model
RM*ES6F16HAU
Catalog number
RM*ES6F16HAU
Device description
GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
Published
2016-09-09
Public version status
Update
Distribution status
Not 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
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34987350718007PackageGS15Not in Commercial Distribution
54987350718001PackageGS14Not in Commercial Distribution
04987350718006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3498735071800734987350718007
5498735071800154987350718001
04987350718006049873507180064987350718006

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator and/or a vascular catheter introduction needle (e.g., arterial needle), and typically an additional access device(s) [e.g., guidewire, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually for arterial access; some sets include in addition noninvasive supportive devices (e.g., drapes, dressings). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length0
Lumen/Inner Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile. Keep dry. Keep away from sunlight. Stacking limit by 11.

Contacts#

Phone, Email table
PhoneEmail
+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
04987350717948GLIDESHEATH SLENDERRM*ES6J10HATRM*ES6J10HAT2016-09-09
04987350717962GLIDESHEATH SLENDERRM*ES6J16HATRM*ES6J16HAT2016-09-09
04987350717986GLIDESHEATH SLENDERRM*ES6F10HAURM*ES6F10HAU2016-09-09
04987350718020GLIDESHEATH SLENDERRM*RS6J10PARM*RS6J10PA2016-09-09
04987350718044GLIDESHEATH SLENDERRM*RS6J16PARM*RS6J16PA2016-09-09
04987350718068GLIDESHEATH SLENDERRM*RS6F10PARM*RS6F10PA2016-09-09
04987350718082GLIDESHEATH SLENDERRM*RS6F16PARM*RS6F16PA2016-09-09
04987350722607GLIDESHEATH SLENDERRM*ES5J10HATRM*ES5J10HAT2016-09-09
04987350722621GLIDESHEATH SLENDERRM*ES5J16HATRM*ES5J16HAT2016-09-09
04987350722645GLIDESHEATH SLENDERRM*ES5F10HAURM*ES5F10HAU2016-09-09
04987350722669GLIDESHEATH SLENDERRM*ES5F16HAURM*ES5F16HAU2016-09-09
04987350722720GLIDESHEATH SLENDERRM*RS5J10PARM*RS5J10PA2016-09-09
04987350722744GLIDESHEATH SLENDERRM*RS5J16PARM*RS5J16PA2016-09-09
04987350722768GLIDESHEATH SLENDERRM*RS5F10PARM*RS5F10PA2016-09-09
04987350722782GLIDESHEATH SLENDERRM*RS5F16PARM*RS5F16PA2016-09-09
04987350723048GLIDESHEATH SLENDERRM*ES7J10HATRM*ES7J10HAT2016-09-09
04987350723062GLIDESHEATH SLENDERRM*ES7J16HATRM*ES7J16HAT2016-09-09
04987350723086GLIDESHEATH SLENDERRM*ES7F10HAURM*ES7F10HAU2016-09-09
04987350723109GLIDESHEATH SLENDERRM*ES7F16HAURM*ES7F16HAU2016-09-09
04987350723161GLIDESHEATH SLENDERRM*RS7J10PARM*RS7J10PA2016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
00389701011912GLIDESHEATH SLENDER TIBIAL PEDAL KITTERUMO MEDICAL CORPORATIONDYB2018-08-31
00389701011950GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
00389701011967GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
00389701011974GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
00389701011981GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
00389701009261PINNACLETERUMO MEDICAL CORPORATIONDYB2018-03-21
00382903840120BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840083BD Introsyte-N Autoguard, BD InstaflashBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840106BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840113BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00389701006161DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006178DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006185DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006192DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006208DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006215DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006222DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006239DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006246DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006253DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006260DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006277DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006796DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006802DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006970DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006987DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006994DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701007007DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701007168DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24