FDA.reportPublic FDA data

Super Sheath

Primary DI
04543527181419
Brand
Super Sheath
Company
TOGO MEDIKIT CO.,LTD.
Model
(16035-06B) BT60Z11PGW038
Published
2016-09-16
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200379000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200379000Super SheathTogo Medikit Co., Ltd.2020-03-19DRE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14543527181416PackageGS110In Commercial Distribution
04543527181419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454352718141614543527181416
04543527181419045435271814194543527181419

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature, in a dry, dark place.

Regulatory Flags#

DUNS number
690724240
Device count
1
DM exempt
true
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
04543527181396Super Sheath(16034-04B) BT40Z11PGW0352016-09-16
04543527181402Super Sheath(16035-05B) BT50Z11PGW0382016-09-16
04543527181426Super Sheath(16035-07B) BT70Z11PGW0382016-09-16
04543527181433Super Sheath(16035-08B) BT80Z11PGW0382016-09-16
04543527181440Super Sheath(16035-09B) BT90Z11TGW0382016-09-16
04543527181457Super Sheath(16036-04B) BT40Z11PPW0352016-09-16
04543527181464Super Sheath(16036-05B) BT50Z11PPW0382016-09-16
04543527181471Super Sheath(16036-06B) BT60Z11PPW0382016-09-16
04543527181488Super Sheath(16036-07B) BT70Z11PPW0382016-09-16
04543527181495Super Sheath(16036-08B) BT80Z11PPW0382016-09-16
04543527181501Super Sheath(16036-09B) BT90Z11TPW0382016-09-16
04543527181518Super Sheath(16037-05B) BT50Z25PPW0382016-09-16
04543527181525Super Sheath(16037-06B) BT60Z25PPW0382016-09-16
04543527181532Super Sheath(16037-07B) BT70Z25PPW0382016-09-16
04543527181549Super Sheath(16037-08B) BT80Z25PPW0382016-09-16
04543527181556Super Sheath(16037-09B) BT90Z25TPW0382016-09-16
04543527181563Super Sheath(15-710B) BT40Z11PGW0352016-09-16
04543527181570Super Sheath(15-711B) BT50Z11PGW0352016-09-16
04543527181587Super Sheath(15-712B) BT60Z11PGW0352016-09-16
04543527181594Super Sheath(15-713B) BT70Z11PGW0352016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450839362Prelude Roadster™Merit Medical Systems, Inc.DYB2026-10-30
00884450838129Prelude Roadster™Merit Medical Systems, Inc.DYB2026-10-29
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
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