Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Surgical instrument/endoscope cleaning utensil, reusable FDA UDI
- Device Name
- Cleaning brushes EUDAMEDThe Nylon Brush provides manual cleaning results for surgical instruments. FDA UDI
- Model / Reference
- MED-10682 EUDAMEDGeneral FDA UDI
- Description
- The Nylon Brush provides manual cleaning results for surgical instruments. FDA UDI
Identifiers
- Catalog Number
- PKPSB205 FDA UDI
- Primary DI / UDI-DI
- 10724995202740 EUDAMEDFDA UDI
- Basic UDI-DI
- 10724995202719M2 EUDAMED
- Direct Marketing DI
- 10724995202740 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
Single Use
No
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
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Surgical instrument/endoscope cleaning utensil, single-use
Cleaning brushes by Sanderson Macleod — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical instrument/endoscope cleaning utensil, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 951e3b0d-92f5-4872-89d5-8e6340281544 61 fields · synced Jul 9, 2026
- FDA UDI 31155cd9-1426-4975-ace2-7bb7ebb18f84 36 fields · synced May 27, 2026