DEFENDO Disposable Biopsy Valve

GUDID 00677964065057

MEDIVATORS INC.

Endoscopic biopsy valve, sterile Endoscopic biopsy valve, sterile Endoscopic biopsy valve, sterile Endoscopic biopsy valve, sterile Endoscopic biopsy valve, sterile Endoscopic biopsy valve, sterile Endoscopic biopsy valve, sterile Endoscopic biopsy valve, sterile Endoscopic biopsy valve, sterile Endoscopic biopsy valve, sterile Endoscopic biopsy valve, sterile Endoscopic biopsy valve, sterile Endoscopic biopsy valve, sterile Endoscopic biopsy valve, sterile Endoscopic biopsy valve, sterile Endoscopic biopsy valve, sterile Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit

• Primary Device ID: 00677964065057
• NIH Device Record Key: a4b49275-4574-49d6-b578-749ddfe82a31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEFENDO Disposable Biopsy Valve
• Version Model Number: 100318
• 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

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00677964065057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090851

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-21

On-Brand Devices [DEFENDO Disposable Biopsy Valve]

• 00677964065064: 100319
• 00677964065057: 100318
• 00677964060267: 100302
• 00677964060212: 100301