ENDOGATOR hybrid irrigation tubing

GUDID 00677964052361

MEDIVATORS INC.

Surgical irrigation tubing set, single-use

• Primary Device ID: 00677964052361
• NIH Device Record Key: 85761abf-ed40-41b7-a7cc-56dde4331ed8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOGATOR hybrid irrigation tubing
• Version Model Number: 100610
• 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: false
• 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
• 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	00677964052361 [Primary]
GS1	10677964052368 [Package]; Package: Carton [10 Units]; In Commercial Distribution
GS1	20677964052365 [Package]; Package: Case [30 Units]; In Commercial Distribution
GS1	40677964009608 [Package]; Contains: 10677964052368; Package: Box [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102855

FDA Product Code

• OCX: Endoscopic Irrigation/Suction System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-09-22

On-Brand Devices [ENDOGATOR hybrid irrigation tubing]

• 00677964081989: 100606B
• 00677964081972: 100605B
• 00677964060861: 100608
• 20677964060858: 100606
• 00677964060830: 100605
• 00677964060113: 100631
• 00677964060106: 100630
• 00677964052361: 100610
• 00677964052354: 100609