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EndoRotor® Catheter Guide
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref CATHGUIDEModel ESS-CONSOLE
Identity
- Trade Name
- EndoRotor Catheter Guide EUDAMEDEndoRotor® Catheter Guide FDA UDI
- Generic Name
- Endoscopic overtube, single-use FDA UDI
- Device Name
- EndoRotor Console EUDAMEDEndoRotor® Catheter Guide FDA UDI
- Model / Reference
- CATHGUIDE EUDAMEDFDA UDIESS-CONSOLE EUDAMED
- Description
- EndoRotor® Catheter Guide FDA UDI
Identifiers
- Catalog Number
- CATHGUIDE FDA UDI
- Primary DI / UDI-DI
- 00854172008254 EUDAMEDFDA UDI
- Basic UDI-DI
- 0854172008EndoRotor7L EUDAMED
- Direct Marketing DI
- 00854172008254 EUDAMED
- 510(k) Number
- K181127 FDA UDI
- FDA Product Code
- PTE FDA UDI
- EMDN Code
- G030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Endoscopic overtube, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1690 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscopic overtube, single-use
EndoRotor® Catheter Guide by Interscope, Inc — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic overtube, single-use.
- Pathfinder® — Neptune Medical · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- Guardus — US Endoscopy · Class II
- Guardus — US Endoscopy · Class II
- endomina platform — Endo Tools Therapeutics · Class II
- Pathfinder — Neptune Medical · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- Flexible Overtube — SB-KAWASUMI LABORATORIES, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Interscope, Inc
Sources (2)
- FDA UDI 7acb23a1-8200-432d-93f1-2ffd59a7e951 36 fields · synced Jul 15, 2026
- EUDAMED 018019f9-f392-4569-9f6f-8c8805706631 61 fields · synced Jul 15, 2026