Pathfinder® Endoscope Overtube GI 110160-2

GUDID 00850006222117

NEPTUNE MEDICAL INC.

Endoscopic overtube, single-use

• Primary Device ID: 00850006222117
• NIH Device Record Key: 425dee73-48e1-42c1-8be4-8d3a255ce75c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pathfinder® Endoscope Overtube
• Version Model Number: GI 110160-2
• Catalog Number: GI 110160-2
• Company DUNS: 075588994
• Company Name: NEPTUNE MEDICAL 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: 8882028401
• Email: info@neptunemedical.com
• Phone: 8882028401
• Email: info@neptunemedical.com
• Phone: 8882028401
• Email: info@neptunemedical.com
• Phone: 8882028401
• Email: info@neptunemedical.com
• Phone: 8882028401
• Email: info@neptunemedical.com
• Phone: 8882028401
• Email: info@neptunemedical.com
• Phone: 8882028401
• Email: info@neptunemedical.com
• Phone: 8882028401
• Email: info@neptunemedical.com
• Phone: 8882028401
• Email: info@neptunemedical.com
• Phone: 8882028401
• Email: info@neptunemedical.com
• Phone: 8882028401
• Email: info@neptunemedical.com
• Phone: 8882028401
• Email: info@neptunemedical.com
• Phone: 8882028401
• Email: info@neptunemedical.com
• Phone: 8882028401
• Email: info@neptunemedical.com
• Phone: 8882028401
• Email: info@neptunemedical.com
• Phone: 8882028401
• Email: info@neptunemedical.com

Device Dimensions

• Length: 110 Centimeter
• Catheter Working Length: 100 Centimeter
• Outer Diameter: 18.5 Millimeter
• Length: 110 Centimeter
• Catheter Working Length: 100 Centimeter
• Outer Diameter: 18.5 Millimeter
• Length: 110 Centimeter
• Catheter Working Length: 100 Centimeter
• Outer Diameter: 18.5 Millimeter
• Length: 110 Centimeter
• Catheter Working Length: 100 Centimeter
• Outer Diameter: 18.5 Millimeter
• Length: 110 Centimeter
• Catheter Working Length: 100 Centimeter
• Outer Diameter: 18.5 Millimeter
• Length: 110 Centimeter
• Catheter Working Length: 100 Centimeter
• Outer Diameter: 18.5 Millimeter
• Length: 110 Centimeter
• Catheter Working Length: 100 Centimeter
• Outer Diameter: 18.5 Millimeter
• Length: 110 Centimeter
• Catheter Working Length: 100 Centimeter
• Outer Diameter: 18.5 Millimeter
• Length: 110 Centimeter
• Catheter Working Length: 100 Centimeter
• Outer Diameter: 18.5 Millimeter
• Length: 110 Centimeter
• Catheter Working Length: 100 Centimeter
• Outer Diameter: 18.5 Millimeter
• Length: 110 Centimeter
• Catheter Working Length: 100 Centimeter
• Outer Diameter: 18.5 Millimeter
• Length: 110 Centimeter
• Catheter Working Length: 100 Centimeter
• Outer Diameter: 18.5 Millimeter
• Length: 110 Centimeter
• Catheter Working Length: 100 Centimeter
• Outer Diameter: 18.5 Millimeter
• Length: 110 Centimeter
• Catheter Working Length: 100 Centimeter
• Outer Diameter: 18.5 Millimeter
• Length: 110 Centimeter
• Catheter Working Length: 100 Centimeter
• Outer Diameter: 18.5 Millimeter
• Length: 110 Centimeter
• Catheter Working Length: 100 Centimeter
• Outer Diameter: 18.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850006222117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211301

FDA Product Code

• FED: Endoscopic Access Overtube, Gastroenterology-Urology

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-15
• Device Publish Date: 2021-06-07

On-Brand Devices [Pathfinder® Endoscope Overtube]

• 00850006222117: GI 110160-2
• 00850006222100: GI 085160-2
• 00850006222094: GI 065160-2
• 00850006222087: GI 110140-2
• 00850006222070: GI 065140-2
• 00850006222063: GI 145110-2
• 00850006222056: GI 085110-2
• 00850006222049: GI 065110-2