ENDOGATOR

GUDID 00677964058417

MEDIVATORS INC.

Surgical irrigation tubing set, single-use

• Primary Device ID: 00677964058417
• NIH Device Record Key: d4a3d01c-47e9-46ad-a0e7-253e7547b727
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOGATOR
• Version Model Number: 100115
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00677964058417 [Primary]
GS1	10677964058414 [Package]; Package: Carton [10 Units]; In Commercial Distribution
GS1	20677964058411 [Package]; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033695

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]

• 20677964066188: 200230B
• 00677964066061: 100130B
• 20677964066041: 100115B
• 20677964060889: 200230P
• 20677964060414: 100136P
• 00677964060359: 100110
• 00677964058950: 100135
• 00677964058516: 200230
• 00677964058509: 200230F
• 00677964058493: 100242
• 00677964058486: 100241
• 00677964058479: 100136
• 00677964058462: 100130
• 00677964058455: 100126
• 00677964058448: 100125
• 00677964058431: 100125F
• 00677964058424: 100116
• 00677964058417: 100115
• 00677964058400: 100105
• 40677964031593: ENDOGATOR Channel Adapter
• 40677964030992: Tubing, Endogator EGP-100, US
• 40677964031524: ENDOGATOR Endoscopy Irrigation Tubing can be used with ENDOGATOR EGP100 Irrigation Pump, Olympu