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EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Bronchoscope
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Bronchoscope FDA UDI
- Generic Name
- Tissue morcellation system handpiece, line-powered FDA UDI
- Device Name
- EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Bronchoscope FDA UDI
- Model / Reference
- 3.2-EPR-BRO-O FDA UDI
- Description
- EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Bronchoscope FDA UDI
Identifiers
- Catalog Number
- 3.2-EPR-BRO-O FDA UDI
- Primary DI / UDI-DI
- 00854172008094 FDA UDI
- FDA Product Code
- PTE FDA UDI
- GMDN Term
- Tissue morcellation system handpiece, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Category: Tissue morcellation system handpiece, line-powered
EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Bronchoscope by Interscope, Inc — Class II — FDA UDI — listed in FDA GUDID
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Interscope, Inc
Sources (1)
- FDA UDI b42daf07-5dd8-4195-af8c-e656aafe30c8 35 fields · synced Jun 6, 2026