DEFENDO Biopsy Valve Irrigator

GUDID 00677964060281

MEDIVATORS INC.

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• Primary Device ID: 00677964060281
• NIH Device Record Key: 789c919b-0a69-4ffc-a845-61e3f2250b0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEFENDO Biopsy Valve Irrigator
• Version Model Number: 100303
• Company DUNS: 068199363
• Company Name: MEDIVATORS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00677964060281 [Primary]
GS1	10677964060288 [Package]; Package: Carton [10 Units]; In Commercial Distribution
GS1	20677964060285 [Package]; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110088

FDA Product Code

• ODC: Endoscope Channel Accessory

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-08-15
• Device Publish Date: 2016-09-21

Devices Manufactured by MEDIVATORS INC.

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