Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Surgical instrument/endoscope cleaning utensil, reusable FDA UDI
- Device Name
- Cleaning brushes EUDAMEDThe Fan Tip Brush 18-inch x 12.7mm diameter provides manual cleaning results for surgical instruments. FDA UDI
- Model / Reference
- MED-10649 EUDAMEDFan Tip FDA UDI
- Description
- The Fan Tip Brush 18-inch x 12.7mm diameter provides manual cleaning results for surgical instruments. FDA UDI
Identifiers
- Catalog Number
- 1B50B3 FDA UDI
- Primary DI / UDI-DI
- 10724995162044 EUDAMEDFDA UDI
- Basic UDI-DI
- 10724995202719M2 EUDAMED
- Direct Marketing DI
- 10724995162044 EUDAMED
- FDA Product Code
- MNL FDA UDI
- EMDN Code
- V070101 ENDOSCOPES CLEANING BRUSHES - FOR GENERIC USE 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
- Austria EUDAMED
- Commercial Distribution
- Not 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
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Cleaning brushes by Sanderson Macleod — 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 | 10724995202719M2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sanderson Macleod
- EUDAMED SRN
- US-MF-000037601
- Authorised Representative
- Regulatory Quality Management Information Source AREU, S.L.U ES-AR-000002139
Sources (2)
- EUDAMED 2a8c5973-0ff9-4778-9ac7-9020e37193a2 61 fields · synced Jul 21, 2026
- FDA UDI 9743b3bc-e874-41e4-be03-522265d82607 36 fields · synced May 30, 2026