GLIDESHEATH SLENDER

Primary DI
30389701012026
Brand
GLIDESHEATH SLENDER
Company
TERUMO MEDICAL CORPORATION
Model
60-1660
Catalog number
60-1660
Device description
GLIDESHEATH SLENDER Access Kit
Published
2018-05-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
30389701012026PackageGS15In Commercial Distribution
50389701012020PackageGS110In Commercial Distribution
00389701012025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038970101202630389701012026
5038970101202050389701012020
00389701012025003897010120253897010120250389701012025

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, 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 typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French
Device Size Text, specify0
Device Size Text, specify0
Length16Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid direct sunlight. Keep Dry.
Special Storage Condition, Specify00Do not store at extreme temperature and humidity

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
131489882
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
00389701006178DESTINATIONRSR02RSR022016-09-24
00389701006208DESTINATIONRSR05RSR052016-09-24
00389701006161DESTINATIONRSR01RSR012016-09-24
00389701006185DESTINATIONRSR03RSR032016-09-24
00389701006192DESTINATIONRSR04RSR042016-09-24
00389701006215DESTINATIONRSR06RSR062016-09-24
00389701006222DESTINATIONRSR07RSR072016-09-24
00389701006239DESTINATIONRSR08RSR082016-09-24
00389701006246DESTINATIONRSR09RSR092016-09-24
00389701006253DESTINATIONRSR10RSR102016-09-24
00389701006260DESTINATIONRSR11RSR112016-09-24
00389701006277DESTINATIONRSR12RSR122016-09-24
00389701006796DESTINATIONRSC01RSC012016-09-24
00389701006802DESTINATIONRSC02RSC022016-09-24
00389701006970DESTINATIONRSR13RSR132016-09-24
00389701006987DESTINATIONRSR15RSR152016-09-24
00389701006994DESTINATIONRSR17RSR172016-09-24
00389701007007DESTINATIONRSR19RSR192016-09-24
00389701007168DESTINATIONRSR14RSR142016-09-24
00389701007175DESTINATIONRSR16RSR162016-09-24

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