EndoRotor® Catheter Guide CATHGUIDE
GUDID 00854172008254
EndoRotor® Catheter Guide
INTERSCOPE, INC
Endoscopic overtube, single-use| Primary Device ID | 00854172008254 |
| NIH Device Record Key | 7acb23a1-8200-432d-93f1-2ffd59a7e951 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EndoRotor® Catheter Guide |
| Version Model Number | CATHGUIDE |
| Catalog Number | CATHGUIDE |
| Company DUNS | 968227913 |
| Company Name | INTERSCOPE, 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 | true |
| 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 | 1-877-420-7299 |
| info@interscopemed.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854172008254 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K181127
FDA Product Code
| PTE | Endoscopic Morcellator Gastroenterology |
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 | 2024-02-19 |
| Device Publish Date | 2024-02-09 |
Devices Manufactured by INTERSCOPE, INC
| 00854172008100 - EndoRotor® 6.0mm Powered Endoscopic Debridement (PED) Catheter | 2024-02-19 EndoRotor® 6.0mm Powered Endoscopic Debridement (PED) Catheter |
| 00854172008117 - EndoRotor® 6.0mm Endoscopic Powered Resection (EPR) Catheter | 2024-02-19 EndoRotor® 6.0mm Endoscopic Powered Resection (EPR) Catheter |
| 00854172008254 - EndoRotor® Catheter Guide | 2024-02-19EndoRotor® Catheter Guide |
| 00854172008254 - EndoRotor® Catheter Guide | 2024-02-19 EndoRotor® Catheter Guide |
| 00854172008094 - EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Bronchoscope | 2021-04-14 EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Bronchoscope |
| 00854172008124 - EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Colonoscope Short | 2021-04-14 EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Colonoscope Short Olympus |
| 00854172008131 - EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Colonoscope Long | 2021-04-14 EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Colonoscope Long Olympus/Pentax |
| 00854172008148 - EndoRotor® 3.2mm Powered Endoscopic Debridement (PED) Catheter – Bronchoscope | 2021-04-14 EndoRotor® 3.2mm Powered Endoscopic Debridement (PED) Catheter – Bronchoscope |
| 00854172008155 - EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Gastroscope Fuji | 2021-04-14 EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Gastroscope Fuji |
Trademark Results [EndoRotor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOROTOR 86447058 5423689 Live/Registered |
Interscope, Inc. 2014-11-06 |
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