Identity
- Trade Name
- Reusable Cleaning Brush EUDAMED8000 Series Reusable Channel Cleaning Brush FDA UDI
- Generic Name
- Surgical instrument/endoscope cleaning utensil, reusable FDA UDI
- Device Name
- Reusable and Disposable Cleaning Brushes EUDAMEDSuction Well Cleaning Brush. HIBC: M45388801 FDA UDI
- Model / Reference
- 8880-10 EUDAMED8880 FDA UDI
- Description
- Suction Well Cleaning Brush. HIBC: M45388801 FDA UDI
Identifiers
- Catalog Number
- 8880 FDA UDI
- Primary DI / UDI-DI
- M45388801 EUDAMEDFDA UDI
- Basic UDI-DI
- ++M453RCBWY EUDAMED
- Unit of Use DI
- M45388800 EUDAMED
- FDA Product Code
- MNL FDA UDI
- EMDN Code
- V070102 DIGESTIVE ENDOSCOPY ENDOSCOPES CLEANING BRUSHES EUDAMED
- GMDN Term
- Surgical instrument/endoscope cleaning utensil, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Reusable Cleaning Brush by Primed Instruments Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++M453RCBWY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- PriMed Instruments Inc.
- EUDAMED SRN
- CA-MF-000002760
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 996cbc21-2907-4558-89bc-3b7b785e3e7d 61 fields · synced Aug 4, 2026
- FDA UDI 038c6671-e442-47b0-a9fd-8c0398a637a7 37 fields · synced May 30, 2026