EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Gastroscope Olymp
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- EndoRotor Catheter 3.2-EPR-EGD-OP EUDAMEDEndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Gastroscope Olymp FDA UDI
- Generic Name
- Tissue morcellation system handpiece, line-powered FDA UDI
- Device Name
- EndoRotor Console EUDAMEDEndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Gastroscope Olympus/Pentax FDA UDI
- Model / Reference
- ESS-CONSOLE EUDAMED3.2-EPR-EDG-OP EUDAMED3.2-EPR-EGD-OP FDA UDI
- Description
- EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Gastroscope Olympus/Pentax FDA UDI
Identifiers
- Catalog Number
- 3.2-EPR-EGD-OP FDA UDI
- Primary DI / UDI-DI
- 00854172008162 EUDAMEDFDA UDI
- Basic UDI-DI
- 0854172008EndoRotor7L EUDAMED
- Direct Marketing DI
- 00854172008162 EUDAMED
- FDA Product Code
- PTE FDA UDI
- EMDN Code
- G030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Tissue morcellation system handpiece, line-powered 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Tissue morcellation system handpiece, line-powered
EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Gastroscope Olymp by Interscope, Inc — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Tissue morcellation system handpiece, line-powered.
- Aveta Disposable Resecting Device 2.9 mm — Meditrina, Inc. · Class II
- Disposable Guidewire — Alton (Shanghai) Medical Instruments Co., Ltd. · Class I
- Air Water Channel Cleaning Adapter + Champion 3-piece Valve Kit — GA HEALTH COMPANY LIMITED · Class I
- Polyp Traps — ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD. · Class I
- 2-piece Cleaning Adapter + 4-piece Valve Kit — GA HEALTH COMPANY LIMITED · Class IIa
- Guide Wires — Changzhou Health Microport Medical Device Co., Ltd · Class IIa
- Aveta Disposable Resecting Device 3.9 mm — Meditrina, Inc. · Class II
- 3-piece valve kit — GA HEALTH COMPANY LIMITED · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Interscope, Inc
Sources (2)
- FDA UDI 1d7d1abd-f723-4225-bd1a-03cb18fa4dee 35 fields · synced Oct 6, 2026
- EUDAMED dc4a2f0e-e56a-4c58-b4ca-a8fdd538abe5 61 fields · synced Jul 30, 2026