R2P Destination Slender

Primary DI
00389701012353
Brand
R2P Destination Slender
Company
TERUMO MEDICAL CORPORATION
Model
GS-R6ST1C10W
Catalog number
GS-R6ST1C10W
Device description
R2P Destination Slender Guiding Sheath
Published
2020-04-10
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

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
50389701012358PackageGS15In Commercial Distribution
00389701012353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038970101235850389701012358
00389701012353003897010123533897010123530389701012353

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge0
Device Size Text, specify0
Length0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Contacts#

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

Regulatory Flags#

DUNS number
131489882
Device count
1
DM exempt
true
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
00389701006161DESTINATIONRSR01RSR012016-09-24
00389701006178DESTINATIONRSR02RSR022016-09-24
00389701006185DESTINATIONRSR03RSR032016-09-24
00389701006192DESTINATIONRSR04RSR042016-09-24
00389701006208DESTINATIONRSR05RSR052016-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-18
00199874352930Transseptal Puncture DevicePROTARYX MEDICAL INC.DYB2026-07-15
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
00685447005285TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005292TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005308TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005315TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005322TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005339TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005346TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005353TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005360TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005377TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005384TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005391TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005407TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005414TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005421TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005438TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005445TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005452TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005469TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005476TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
10801902190519ARROWTELEFLEX INCORPORATEDDYB2021-09-02
00685447005605SupraCross Steerable SheathBaylis Médicale Cie IncDYB2021-04-19
00685447005612SupraCross Steerable SheathBaylis Médicale Cie IncDYB2021-04-19
00685447005629SupraCross Steerable SheathBaylis Médicale Cie IncDYB2021-04-19
00685447005643SureFlex Steerable Guiding SheathBaylis Médicale Cie IncDYB2021-04-19
00685447005650SureFlex Steerable Guiding SheathBaylis Médicale Cie IncDYB2021-04-19
00389701012360R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10