Identity
- Trade Name
- Sharn Brushes FDA UDI
- Generic Name
- Surgical instrument/endoscope cleaning utensil, reusable FDA UDI
- Device Name
- Sharn Brushes EUDAMEDFrazier (Baron) Brush 10" / 250mm, 8FR FDA UDI
- Model / Reference
- 30622 EUDAMEDFDA UDI
- Description
- Frazier (Baron) Brush 10" / 250mm, 8FR FDA UDI
Identifiers
- Catalog Number
- 30622 FDA UDI
- Primary DI / UDI-DI
- 00690521013650 EUDAMEDFDA UDI
- Basic UDI-DI
- 6905210SBRUSH1000ZQ 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
- 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
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
Sharn 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 | 6905210SBRUSH1000ZQ | 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 b32347ac-1d84-4c6b-b0ae-c164d816e999 61 fields · synced Jun 17, 2026
- FDA UDI d6636b87-a5ee-424c-a650-b773de0d5f3e 36 fields · synced May 30, 2026