Pathfinder® Endoscope Overtube with Balloon GI 110140B-1

GUDID 00850006222124

NEPTUNE MEDICAL INC.

Endoscopic overtube, single-use

• Primary Device ID: 00850006222124
• NIH Device Record Key: 8adb0e90-87ce-4585-af3f-05f35c556514
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pathfinder® Endoscope Overtube with Balloon
• Version Model Number: GI 085140B-1
• Catalog Number: GI 110140B-1
• 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
• Phone: 8882028401
• Email: info@neptunemedical.com

Device Dimensions

• Length: 85 Centimeter
• Catheter Working Length: 75 Centimeter
• Outer Diameter: 14 Millimeter
• Length: 85 Centimeter
• Catheter Working Length: 75 Centimeter
• Outer Diameter: 14 Millimeter
• Length: 85 Centimeter
• Catheter Working Length: 75 Centimeter
• Outer Diameter: 14 Millimeter
• Length: 85 Centimeter
• Catheter Working Length: 75 Centimeter
• Outer Diameter: 14 Millimeter
• Length: 85 Centimeter
• Catheter Working Length: 75 Centimeter
• Outer Diameter: 14 Millimeter
• Length: 85 Centimeter
• Catheter Working Length: 75 Centimeter
• Outer Diameter: 14 Millimeter
• Length: 85 Centimeter
• Catheter Working Length: 75 Centimeter
• Outer Diameter: 14 Millimeter
• Length: 85 Centimeter
• Catheter Working Length: 75 Centimeter
• Outer Diameter: 14 Millimeter
• Length: 85 Centimeter
• Catheter Working Length: 75 Centimeter
• Outer Diameter: 14 Millimeter
• Length: 85 Centimeter
• Catheter Working Length: 75 Centimeter
• Outer Diameter: 14 Millimeter
• Length: 85 Centimeter
• Catheter Working Length: 75 Centimeter
• Outer Diameter: 14 Millimeter
• Length: 85 Centimeter
• Catheter Working Length: 75 Centimeter
• Outer Diameter: 14 Millimeter
• Length: 85 Centimeter
• Catheter Working Length: 75 Centimeter
• Outer Diameter: 14 Millimeter
• Length: 85 Centimeter
• Catheter Working Length: 75 Centimeter
• Outer Diameter: 14 Millimeter
• Length: 85 Centimeter
• Catheter Working Length: 75 Centimeter
• Outer Diameter: 14 Millimeter
• Length: 85 Centimeter
• Catheter Working Length: 75 Centimeter
• Outer Diameter: 14 Millimeter
• Length: 85 Centimeter
• Catheter Working Length: 75 Centimeter
• Outer Diameter: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850006222124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230801

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: 2023-11-28
• Device Publish Date: 2023-11-20

On-Brand Devices [Pathfinder® Endoscope Overtube with Balloon]

• 00850006222124: GI 085140B-1
• 00850006222025: GI 110140B-1