FDA.reportPublic FDA data

RAIN Sheath Transradial

Primary DI
10705032078986
Brand
RAIN Sheath Transradial
Company
Cordis US Corp.
Model
506716S
Catalog number
506716S
Device description
7F16cm SW Radial
Published
2018-10-09
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

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
20705032078983PackageGS15In Commercial Distribution
10705032078986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503207898320705032078983
1070503207898610705032078986

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
118274128
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
10705032000086RAIN Sheath® Tibial Pedal IntroducerTP506410NTP506410N2023-05-05
10705032000093RAIN Sheath® Tibial Pedal IntroducerTP506410STP506410S2023-05-05
10705032078894RAIN Sheath Transradial506616H506616H2018-10-09
10705032078924RAIN Sheath Transradial506716H506716H2018-10-09
10705032078931RAIN Sheath Transradial506416S506416S2018-10-09
10705032078948RAIN Sheath Transradial506610S506610S2018-10-09
10705032078955RAIN Sheath Transradial506710S506710S2018-10-09
10705032078962RAIN Sheath Transradial506410H506410H2018-10-09
10705032078979RAIN Sheath Transradial506510H506510H2018-10-09
10705032078993RAIN Sheath Transradial506416H506416H2018-10-09
10705032079006RAIN Sheath Transradial506616S506616S2018-10-09
10705032079013RAIN Sheath Transradial506710H506710H2018-10-09
10705032079037RAIN Sheath Transradial506610H506610H2018-10-09
10705032082068RAIN Sheath Transradial506410P20G506410P20G2020-12-17
10705032082075RAIN Sheath Transradial506716P22G506716P22G2020-12-17
10705032082082RAIN Sheath Transradial506616P22G506616P22G2020-12-17
10705032082105RAIN Sheath Transradial506510P22G506510P22G2020-12-17
10705032082112RAIN Sheath Transradial506510P20G506510P20G2020-12-17
10705032082129RAIN Sheath Transradial506516N506516N2020-12-17
10705032082136RAIN Sheath Transradial506616N506616N2020-12-17

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