ENDOGATOR Kit

GUDID 20677964070437

MEDIVATORS INC.

Surgical irrigation tubing set, single-use

• Primary Device ID: 20677964070437
• NIH Device Record Key: 9442f0c4-982f-4a21-95d4-bae8674417ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOGATOR Kit
• Version Model Number: 100655B
• 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: true
• 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	00677964070433 [Primary]
GS1	20677964070437 [Package]; Contains: 00677964070433; Package: Case [20 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: 3
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-08-16

On-Brand Devices [ENDOGATOR Kit]

• 20677964070468: 100658B
• 20677964070437: 100655B
• 20677964068953: 100653B
• 20677964068946: 100650B
• 20677964067383: 100623B
• 20677964067376: 100622B
• 00677964067358: 100620B
• 20677964065372: 100658
• 20677964065365: 100657
• 20677964065358: 100656
• 20677964065341: 100655
• 20677964065334: 100654
• 20677964065327: 100653
• 20677964065310: 100652
• 20677964065303: 100651
• 20677964065297: 100650
• 20677964056967: 100629
• 20677964056950: 100628
• 20677964056943: 100627
• 20677964056936: 100626
• 20677964056929: 100625
• 20677964056912: 100623
• 20677964056905: 100622
• 20677964056899: 100621
• 20677964056882: 100620
• 20677964056523: 100618
• 20677964056516: 100616
• 20677964056509: 100615
• 20677964056493: 100614
• 20677964056486: 100613
• 20677964052440: 100612
• 20677964052433: 100611
• 20677964067284: ENDOGATOR Kit contains the ENDOGATOR Irrigation Tubing for Boston Scientific ENDOSTAT II, Olympu
• 40677964028142: Endogator Kit includes Endogator Irrigation Tubing for Endogator EGP-100 Irrigation pump, Olympu
• 40677964028111: Endogator Kit includes Endogator Irrigation Tubing compatible with Boston Scientific Endostat II
• 40677964027992: Endagator Kit includes Endogator Irrigation Tubing, for Endogator EGP-100 Irrigation pump, Olymp
• 10677964059640: EndoGator Hybrid Tubing Kit for use with Endogator Irrigation Pump, Olympus Pump, gi4000 ESU, an