DEFENDO Biopsy Valve Irrigator

GUDID 00677964060281

MEDIVATORS INC.

Endoscopic biopsy valve, sterile

• 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

Customer Support Contacts

• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com

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.

• 00724995360191 - NA: 2026-02-12 Endo Leak Kit contains Endo Leak Tester, ACMI Adapter, Calibration Adapter, Calibration Gauge, and power supply.
• 00724995360207 - NA: 2026-02-12 Endo Leak Kit contains Endo Leak Tester, Fujifilm Adapter, Calibration Adapter, Calibration Gauge, and power supply.
• 00724995360214 - NA: 2026-02-12 Endo Leak Kit contains Endo Leak Tester, Olympus Adapter, Calibration Adapter, Calibration Gauge, and power supply.
• 00724995360221 - NA: 2026-02-12 Endo Leak Kit contains Endo Leak Tester, Pentax Adapter, Calibration Adapter, Calibration Gauge, and power supply.
• 00724995360238 - NA: 2026-02-12 Endo Leak Kit contains Endo Leak Tester, Storz Adapter, Calibration Adapter, Calibration Gauge, and power supply.
• 00724995360245 - NA: 2026-02-12 Endo Leak Kit contains Endo Leak Tester, Wolf Adapter, Calibration Adapter, Calibration Gauge, and power supply.
• 50677964151892 - Endo Carry-on Procedure Kit: 2026-02-09 Endo Carry-on Procedure Kit contains Basin, VIA Enzymatic Sponge, Defendo Olympus 5-Piece Kit, Transport Pad, Gauze, Lubricant,
• 50677964151908 - Endo Carry-on Procedure Kit: 2026-02-09 Endo Carry-on Procedure Kit contains Intercept Bedside Kit, VIA Enzymatic Sponge, Defendo Olympus 4-Piece Kit, Transport Pad, Ga