Identity
- Trade Name
- Batrik Brush/Blue/BD 8mm/BL 50mm-SNG FDA UDI
- Generic Name
- Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
- Device Name
- Brushes EUDAMEDBrush/Blue/BD 8mm/BL 50mm/OL 75cm - Rigid - SINGLE USE FDA UDI
- Model / Reference
- 41-80008-S EUDAMEDFDA UDI
- Description
- Brush/Blue/BD 8mm/BL 50mm/OL 75cm - Rigid - SINGLE USE FDA UDI
Identifiers
- Catalog Number
- 41-80008-S FDA UDI
- Primary DI / UDI-DI
- 00690521008946 EUDAMEDFDA UDI
- Basic UDI-DI
- 6905210BRUSH10007A EUDAMED
- FDA Product Code
- MNL FDA UDI
- EMDN Code
- V070105 INSTRUMENTS CLEANING BRUSHES EUDAMED
- GMDN Term
- Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
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
Yes
FDA UDI
Brushes by Batrik Medical Manufacturing 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 | 6905210BRUSH10007A | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Batrik Medical Manufacturing Inc.
- EUDAMED SRN
- CA-MF-000007738
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 078b3070-7bc2-41c3-8f13-c5ff811ea607 61 fields · synced Jul 14, 2026
- FDA UDI c2739597-7ea4-4609-9c8f-dea0b667183b 36 fields · synced May 29, 2026