Super Sheath Introducer Sheath

GUDID 74543527226898

TOGO MEDIKIT CO.,LTD.

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• Primary Device ID: 74543527226898
• NIH Device Record Key: 9132c54e-62f6-4ec7-b7db-092dacb23952
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Super Sheath Introducer Sheath
• Version Model Number: (S-3N7/0892)BT33Z07PPW025
• 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

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Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04543527226899 [Primary]
GS1	14543527226896 [Package]; Contains: 04543527226899; Package: Box [5 Units]; In Commercial Distribution
GS1	74543527226898 [Package]; Contains: 14543527226896; Package: Carton [45 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121504

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 Introducer Sheath]

• 14543527226919: (S-3W7/0894)BT33Z07PGW025
• 14543527226902: (S-3W5/0893)BT33Z05PGW025
• 74543527226898: (S-3N7/0892)BT33Z07PPW025
• 74543527226881: (S-3N5/0891)BT33Z05PPW025
• 14543527199763: (S-3W7/0898)BT33Z07PGW018
• 14543527199756: (S-3W5/0897)BT33Z05PGW018
• 74543527199741: (S-3N7/0896)BT33Z07PPW018
• 74543527199734: (S-3N5/0895)BT33Z05PPW018