EndoRotor® Purge Kit (Box of 10)
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- EndoRotor Purge Kit EUDAMEDEndoRotor® Purge Kit (Box of 10) FDA UDI
- Generic Name
- Surgical suction system collection container, single-use FDA UDI
- Device Name
- EndoRotor Console EUDAMED
- Model / Reference
- ESS-CONSOLE EUDAMEDPED-PURGE EUDAMEDER 60-01 FDA UDI
Identifiers
- Catalog Number
- ER 60-01 FDA UDI
- Primary DI / UDI-DI
- 10854172008237 EUDAMED10854172008084 FDA UDI
- Basic UDI-DI
- 0854172008EndoRotor7L EUDAMED
- Direct Marketing DI
- 10854172008237 EUDAMED
- FDA Product Code
- PTE FDA UDI
- EMDN Code
- G030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Surgical suction system collection container, 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
No
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
No
Manufacturing Date
Yes
Category: Surgical suction system collection container, single-use
EndoRotor® Purge Kit (Box of 10) by Interscope, Inc — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Interscope, Inc
Sources (2)
- FDA UDI 2e3c1d76-7312-4baa-9c45-34e374f3b754 34 fields · synced Jul 9, 2026
- EUDAMED 0b2e88ab-d900-455f-827b-42cd41720872 61 fields · synced Jul 9, 2026