FDA.reportPublic FDA data

Super Sheath XL

Primary DI
74543527202021
Brand
Super Sheath XL
Company
TOGO MEDIKIT CO.,LTD.
Model
(15-739B) CI14L25TP0038
Published
2021-02-09
Public version status
Update
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
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060190000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060190000SUPER SHEATH XL INTRODUCER SHEATHTogo Medikit Co., Ltd.2006-04-04DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14543527202029PackageGS11In Commercial Distribution
74543527202021PackageGS150In Commercial Distribution
04543527202022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454352720202914543527202029
7454352720202174543527202021
04543527202022045435272020224543527202022

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
Device Size Text, specify0

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690724240
Device count
1
DM exempt
true
Kit
true
Lot or batch
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
00884450840610Prelude Roadster™Merit Medical Systems, Inc.DYB2026-10-20
00821329003455GORE GUIDRA Steerable SheathGreatbatch LtdDYB2026-10-14
00821329003462GORE GUIDRA Steerable SheathGreatbatch LtdDYB2026-10-14
00733132658855GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658862GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658879GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658886GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658893GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658909GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658916GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658923GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658930GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658947GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658954GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658961GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658978GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658985GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658992GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659005GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659012GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659029GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659036GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659043GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659050GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659067GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00850291007475Triever LA Transseptal SheathInari Medical, Inc.DYB2024-04-15
00810123710430ClotTriever SheathInari Medical, Inc.DYB2023-12-15
00733132629985GORE DRYSEAL FLEX Introducer SheathW. L. Gore & Associates, Inc.DYB2023-05-25
00733132628285GORE DRYSEAL FLEX Introducer SheathW. L. Gore & Associates, Inc.DYB2020-07-11
00733132628308GORE DRYSEAL FLEX Introducer SheathW. L. Gore & Associates, Inc.DYB2020-07-11