FDA.reportPublic FDA data

Super Sheath

Primary DI
04543527267182
Brand
Super Sheath
Company
TOGO MEDIKIT CO.,LTD.
Model
BT80Z11PGW038
Published
2025-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DREDilator, Vessel, For Percutaneous Catheterization
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2
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
14543527267189PackageGS110In Commercial Distribution
04543527267182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454352726718914543527267189
04543527267182045435272671824543527267182

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 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.

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
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04543527266895Super Sheath XLCI10L11TG00352025-03-13
04543527266901Super Sheath XLCI10L11TP00382025-03-13
04543527266918Super Sheath XLCI11L11TG00352025-03-13
04543527266925Super Sheath XLCI11L11TP00382025-03-13
04543527266932Super Sheath XLCI12L11TG00352025-03-13
04543527266949Super Sheath XLCI12L11TP00382025-03-13
04543527266956Super Sheath XLCI14L11TG00352025-03-13
04543527266963Super Sheath XLCI14L11TP00382025-03-13
04543527266970Super Sheath XLCI10L25TP00382025-03-13
04543527266987Super Sheath XLCI11L25TP00382025-03-13
04543527266994Super Sheath XLCI12L25TP00382025-03-13
04543527267007Super Sheath XLCI14L25TP00382025-03-13
04543527267014Super SheathBT40Z07PGW0352025-03-13
04543527267021Super SheathBT50Z07PGW0352025-03-13
04543527267038Super SheathBT60Z07PGW0352025-03-13
04543527267045Super SheathBT60Z07PGW0382025-03-13
04543527267052Super SheathBT70Z07PGW0352025-03-13
04543527267076Super SheathBT40Z11PPW0352025-03-13
04543527267083Super SheathBT50Z11PGW0352025-03-13
04543527267090Super SheathBT50Z11PGW0382025-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850291007475Triever LA Transseptal SheathInari Medical, Inc.DYB2024-04-15
00810123710430ClotTriever SheathInari Medical, Inc.DYB2023-12-15
00821329000676OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000683OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000690OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000706OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000720OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000737OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000744OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000751OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000768OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000775OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000782OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000799OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000805OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000812OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000829OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000843OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000850OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000867OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000874OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000881OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000898OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000904OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000911OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000928OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000935OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000942OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000966OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000973OptiSeal™Greatbatch LtdDYB2019-08-15