Pathfinder GI 085140-2
GUDID 00850006222018
NEPTUNE MEDICAL INC.
Endoscopic overtube, single-use| Primary Device ID | 00850006222018 |
| NIH Device Record Key | 3129373f-0e27-4c18-a96a-e6fe974f2c5c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pathfinder |
| Version Model Number | GI 085140-2 |
| Catalog Number | GI 085140-2 |
| 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
Device Dimensions
| Length | 85 Centimeter |
| Outer Diameter | 16.5 Millimeter |
| Length | 85 Centimeter |
| Outer Diameter | 16.5 Millimeter |
| Length | 85 Centimeter |
| Outer Diameter | 16.5 Millimeter |
| Length | 85 Centimeter |
| Outer Diameter | 16.5 Millimeter |
| Length | 85 Centimeter |
| Outer Diameter | 16.5 Millimeter |
| Length | 85 Centimeter |
| Outer Diameter | 16.5 Millimeter |
| Length | 85 Centimeter |
| Outer Diameter | 16.5 Millimeter |
| Length | 85 Centimeter |
| Outer Diameter | 16.5 Millimeter |
| Length | 85 Centimeter |
| Outer Diameter | 16.5 Millimeter |
| Catheter Working Length | 75 Centimeter |
| Length | 85 Centimeter |
| Outer Diameter | 16.5 Millimeter |
| Catheter Working Length | 75 Centimeter |
| Length | 85 Centimeter |
| Outer Diameter | 16.5 Millimeter |
| Catheter Working Length | 75 Centimeter |
| Length | 85 Centimeter |
| Outer Diameter | 16.5 Millimeter |
| Catheter Working Length | 75 Centimeter |
| Length | 85 Centimeter |
| Outer Diameter | 16.5 Millimeter |
| Catheter Working Length | 75 Centimeter |
| Length | 85 Centimeter |
| Outer Diameter | 16.5 Millimeter |
| Catheter Working Length | 75 Centimeter |
| Length | 85 Centimeter |
| Outer Diameter | 16.5 Millimeter |
| Catheter Working Length | 75 Centimeter |
| Length | 85 Centimeter |
| Outer Diameter | 16.5 Millimeter |
| Catheter Working Length | 75 Centimeter |
| Length | 85 Centimeter |
| Outer Diameter | 16.5 Millimeter |
| Catheter Working Length | 75 Centimeter |
| Length | 85 Centimeter |
| Outer Diameter | 16.5 Millimeter |
| Catheter Working Length | 75 Centimeter |
| Length | 85 Centimeter |
| Outer Diameter | 16.5 Millimeter |
| Catheter Working Length | 75 Centimeter |
| Length | 85 Centimeter |
| Outer Diameter | 16.5 Millimeter |
| Catheter Working Length | 75 Centimeter |
| Length | 85 Centimeter |
| Outer Diameter | 16.5 Millimeter |
| Catheter Working Length | 75 Centimeter |
| Length | 85 Centimeter |
| Outer Diameter | 16.5 Millimeter |
| Catheter Working Length | 75 Centimeter |
| Length | 85 Centimeter |
| Outer Diameter | 16.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850006222018 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191415
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 | 2021-02-05 |
| Device Publish Date | 2021-01-28 |
Devices Manufactured by NEPTUNE MEDICAL INC.
| 00850006222322 - Pathfinder® CR System | 2024-07-17 The Pathfinder® CR System is a disposable endoscopy fluid management system for the 14mm ID Pathfinder®Endoscope Overtube. It |
| 00850006222025 - Pathfinder® Endoscope Overtube with Balloon | 2023-11-28 |
| 00850006222124 - Pathfinder® Endoscope Overtube with Balloon | 2023-11-28 |
| 00850006222049 - Pathfinder® Endoscope Overtube | 2021-09-08 |
| 00850006222056 - Pathfinder® Endoscope Overtube | 2021-09-08 |
| 00850006222063 - Pathfinder® Endoscope Overtube | 2021-09-08 |
| 00850006222070 - Pathfinder® Endoscope Overtube | 2021-06-15 |
| 00850006222087 - Pathfinder® Endoscope Overtube | 2021-06-15 |
Trademark Results [Pathfinder]
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