Super Sheath

GUDID 74543527202175

TOGO MEDIKIT CO.,LTD.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 74543527202175
• NIH Device Record Key: eac31f78-b698-4fe7-a156-a6cef79c8522
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Super Sheath
• Version Model Number: (39086-26B) BT70Z25PPW035
• Company DUNS: 690724240
• Company Name: TOGO MEDIKIT CO.,LTD.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04543527202176 [Primary]
GS1	14543527202173 [Package]; Contains: 04543527202176; Package: Box [1 Units]; In Commercial Distribution
GS1	74543527202175 [Package]; Contains: 14543527202173; Package: Carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141070

FDA Product Code

• DYB: INTRODUCER, CATHETER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2016-09-16

On-Brand Devices [Super Sheath]

• 74543527202809: (15-708B) BT80Z07PGW035
• 14543527202791: (15-707B) BT70Z07PGW035
• 14543527202784: (15-706B) BT60Z07PGW035
• 14543527202777: (15-705B) BT50Z07PGW035
• 14543527202760: (15-704B) BT40Z07PGW035
• 14543527202586: (15-734B) BT90Z25TPW038
• 14543527202579: (15-733B) BT80Z25PPW038
• 74543527202564: (15-732B) BT70Z25PPW038
• 14543527202555: (15-731B) BT60Z25PPW038
• 14543527202548: (15-730B) BT50Z25PPW038
• 14543527202531: (15-725B) BT90Z11TPW038
• 14543527202524: (15-724B) BT80Z11PPW038
• 14543527202517: (15-723B) BT70Z11PPW038
• 74543527202502: (15-722B) BT60Z11PPW038
• 74543527202496: (15-721B) BT50Z11PPW038
• 74543527202489: (15-720B) BT40Z11PPW035
• 14543527202470: (15-715B) BT90Z11TGW035
• 74543527202465: (15-714B) BT80Z11PGW035
• 14543527202456: (15-713B) BT70Z11PGW035
• 74543527202441: (15-712B) BT60Z11PGW035
• 74543527202434: (15-711B) BT50Z11PGW035
• 74543527202427: (15-710B) BT40Z11PGW035
• 74543527202410: (16037-09B) BT90Z25TPW038
• 74543527202403: (16037-08B) BT80Z25PPW038
• 74543527202397: (16037-07B) BT70Z25PPW038
• 74543527202380: (16037-06B) BT60Z25PPW038
• 74543527202373: (16037-05B) BT50Z25PPW038
• 74543527202366: (16036-09B) BT90Z11TPW038
• 74543527202359: (16036-08B) BT80Z11PPW038
• 74543527202342: (16036-07B) BT70Z11PPW038
• 14543527202333: (16036-06B) BT60Z11PPW038
• 14543527202326: (16036-05B) BT50Z11PPW038
• 14543527202319: (16036-04B) BT40Z11PPW035
• 74543527202304: (16035-09B) BT90Z11TGW038
• 14543527202296: (16035-08B) BT80Z11PGW038
• 14543527202289: (16035-07B) BT70Z11PGW038
• 74543527202274: (16035-06B) BT60Z11PGW038
• 74543527202267: (16035-05B) BT50Z11PGW038
• 14543527202258: (16034-04B) BT40Z11PGW035
• 14543527202241: (39086-33B) BT90Z07TGW038
• 14543527202234: (39086-32B) BT80Z07PGW038
• 14543527202227: (39086-31B) BT70Z07PGW038
• 14543527202210: (39086-30B) BT60Z07PGW038
• 14543527202203: (39086-29B) BT50Z07PGW038
• 74543527202199: (39086-28B) BT90Z25TPW035
• 74543527202182: (39086-27B) BT80Z25PPW035
• 74543527202175: (39086-26B) BT70Z25PPW035
• 74543527202168: (39086-25B) BT60Z25PPW035
• 14543527202159: (39086-24B) BT50Z25PPW035
• 14543527202142: (39086-23B) BT40Z25PPW035