Super Sheath R/O

GUDID 14543527181799

TOGO MEDIKIT CO.,LTD.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 14543527181799
• NIH Device Record Key: a470db2a-805e-44e3-883d-e9f5c058f2be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Super Sheath R/O
• Version Model Number: (15-961B) BT50Z11PPWX38
• 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.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.
• 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	04543527181792 [Primary]
GS1	14543527181799 [Package]; Contains: 04543527181792; Package: Box [10 Units]; In Commercial Distribution
GS1	74543527181791 [Package]; Package: Carton [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141070
• Premarket Notification: K200379

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 R/O]

• 14543527202753: (15-968B) BT90Z25TPWX38
• 74543527202748: (15-967B) BT80Z25PPWX38
• 74543527202731: (15-966B) BT70Z25PPWX38
• 14543527202722: (15-965B) BT60Z25PPWX38
• 74543527202717: (15-971B) BT50Z25PPWX38
• 74543527202700: (15-970B) BT40Z25PPWX35
• 74543527202694: (15-969B) BT90Z11TPWX38
• 74543527202687: (15-964B) BT80Z11PPWX38
• 14543527202678: (15-963B) BT70Z11PPWX38
• 74543527202663: (15-962B) BT60Z11PPWX38
• 14543527202654: (15-961B) BT50Z11PPWX38
• 74543527202649: (15-960B) BT40Z11PPWX35
• 14543527202630: (15-955B) BT90Z07TPWX38
• 74543527202625: (15-959B) BT80Z07PPWX38
• 14543527202616: (15-958B) BT70Z07PPWX38
• 74543527202601: (15-957B) BT60Z07PPWX38
• 14543527202593: (15-956B) BT50Z07PPWX38
• 74543527181890: (15-968B) BT90Z25TPWX38
• 14543527181881: (15-967B) BT80Z25PPWX38
• 74543527181876: (15-966B) BT70Z25PPWX38
• 14543527181867: (15-965B) BT60Z25PPWX38
• 14543527181850: (15-971B) BT50Z25PPWX38
• 74543527181845: (15-970B) BT40Z25PPWX35
• 74543527181838: (15-969B) BT90Z11TPWX38
• 74543527181821: (15-964B) BT80Z11PPWX38
• 74543527181814: (15-963B) BT70Z11PPWX38
• 14543527181805: (15-962B) BT60Z11PPWX38
• 14543527181799: (15-961B) BT50Z11PPWX38
• 14543527181782: (15-960B) BT40Z11PPWX35
• 14543527181775: (15-955B) BT90Z07TPWX38
• 74543527181760: (15-959B) BT80Z07PPWX38
• 14543527181751: (15-958B) BT70Z07PPWX38
• 14543527181744: (15-957B) BT60Z07PPWX38
• 14543527181737: (15-956B) BT50Z07PPWX38
• 14543527202746: (15-967B) BT80Z25PPWX38
• 14543527202739: (15-966B) BT70Z25PPWX38
• 14543527202715: (15-971B) BT50Z25PPWX38
• 14543527202708: (15-970B) BT40Z25PPWX35
• 14543527202692: (15-969B) BT90Z11TPWX38
• 14543527202685: (15-964B) BT80Z11PPWX38
• 14543527202661: (15-962B) BT60Z11PPWX38
• 14543527202647: (15-960B) BT40Z11PPWX35
• 14543527202623: (15-959B) BT80Z07PPWX38
• 14543527202609: (15-957B) BT60Z07PPWX38
• 14543527181898: (15-968B) BT90Z25TPWX38
• 14543527181874: (15-966B) BT70Z25PPWX38
• 14543527181843: (15-970B) BT40Z25PPWX35
• 14543527181836: (15-969B) BT90Z11TPWX38
• 14543527181829: (15-964B) BT80Z11PPWX38
• 14543527181812: (15-963B) BT70Z11PPWX38