ENDOGATOR Hybrid Irrigation Tubing

GUDID 00677964060113

MEDIVATORS INC.

Surgical irrigation tubing set, single-use

• Primary Device ID: 00677964060113
• NIH Device Record Key: 0f4b4519-5746-47dd-9d1f-2fbaf97a1f8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOGATOR Hybrid Irrigation Tubing
• Version Model Number: 100631
• 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	00677964060113 [Primary]
GS1	10677964060110 [Package]; Package: Carton [10 Units]; In Commercial Distribution
GS1	20677964060117 [Package]; Package: Case [30 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