FDA.reportPublic FDA data

Super Sheath

Primary DI
14543527267196
Brand
Super Sheath
Company
TOGO MEDIKIT CO.,LTD.
Model
BT80Z11PPW038
Published
2025-03-13
Public version status
New
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
DREDilator, Vessel, For Percutaneous Catheterization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2

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
14543527267196PackageGS110In Commercial Distribution
04543527267199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454352726719614543527267196
04543527267199045435272671994543527267199

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
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
04543527181419Super Sheath(16035-06B) BT60Z11PGW0382016-09-16
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450499191Merit MAK™Merit Medical Systems, Inc.DRE2026-10-30
00884450499221Merit MAK™Merit Medical Systems, Inc.DRE2026-10-30
00884450499245Merit MAK™Merit Medical Systems, Inc.DRE2026-10-30
00884450499870Merit S-MAK™Merit Medical Systems, Inc.DRE2026-10-30
00884450839362Prelude Roadster™Merit Medical Systems, Inc.DRE2026-10-30
00884450838129Prelude Roadster™Merit Medical Systems, Inc.DRE2026-10-29
10884450708443Prelude®Merit Medical Systems, Inc.DRE2026-10-29
00884450840610Prelude Roadster™Merit Medical Systems, Inc.DRE2026-10-20
00884450838105Prelude Roadster™Merit Medical Systems, Inc.DRE2026-10-03
00884450839119Prelude Roadster™Merit Medical Systems, Inc.DRE2026-10-03
00884450838143Prelude Roadster™Merit Medical Systems, Inc.DRE2026-09-03
00884450839126Prelude Roadster™Merit Medical Systems, Inc.DRE2026-09-03
00884450838204Prelude Roadster™Merit Medical Systems, Inc.DRE2026-09-02
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DRE2026-08-27
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DRE2026-08-18
00884450838136Prelude Roadster™Merit Medical Systems, Inc.DRE2026-07-31
00884450839133Prelude Roadster™Merit Medical Systems, Inc.DRE2026-06-19
00884450839140Prelude Roadster™Merit Medical Systems, Inc.DRE2026-05-09
00884450838365Abiomed®Merit Medical Systems, Inc.DRE2025-07-01
00884450770764Prelude Roadster™Merit Medical Systems, Inc.DRE2023-12-13
00884450770771Prelude Roadster™Merit Medical Systems, Inc.DRE2023-10-28
00884450770788Prelude Roadster™Merit Medical Systems, Inc.DRE2023-10-11
00884450770757Prelude Roadster™Merit Medical Systems, Inc.DRE2023-10-05
00884450732311Abiomed®Merit Medical Systems, Inc.DRE2023-06-30
00884450532577Prelude Roadster™Merit Medical Systems, Inc.DRE2022-12-28
00884450532522Prelude Roadster™Merit Medical Systems, Inc.DRE2022-12-15
00884450531952Prelude Roadster™Merit Medical Systems, Inc.DRE2022-11-12
00884450532348Prelude Roadster™Merit Medical Systems, Inc.DRE2022-11-01
00884450532171Prelude Roadster™Merit Medical Systems, Inc.DRE2022-10-28
00884450531914Prelude Roadster™Merit Medical Systems, Inc.DRE2022-10-19