FDA.reportPublic FDA data

Super Sheath

Primary DI
04543527196307
Brand
Super Sheath
Company
TOGO MEDIKIT CO.,LTD.
Model
(39086-03B) BT60Z07PGW035
Published
2016-09-16
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
K141070000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141070000SUPER SHEATHTogo Medikit Co., Ltd.2015-01-15DRE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14543527196304PackageGS110Not in Commercial Distribution
04543527196307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454352719630414543527196304
04543527196307045435271963074543527196307

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
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
10801902228700ARROWTELEFLEX INCORPORATEDDYB2026-09-22
10884450489809Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489816Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489823Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489830Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489847Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489854Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489861Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489878Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489885Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489892Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489908Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489915Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489922Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489939Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489946Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489953Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489960Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489977Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489984Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450495091Hydrophilic Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450510602Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10884450510640Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10884450510664Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10801902227109ARROWTELEFLEX INCORPORATEDDYB2026-09-03
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-27
06974949030920CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
06974949030944CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
10801902227246ARROWTELEFLEX INCORPORATEDDYB2026-08-27
10884450119836Prelude EASE™Merit Medical Systems, Inc.DYB2026-08-27