Identity
- Trade Name
- Fistula Brush FDA UDI
- Generic Name
- General-purpose cytology brush FDA UDI
- Device Name
- The Fistula Brush can be used for probing of the fistula tract and for debridement before using the OTSC Proctology • it is used to clean the fistula tract and remove granulation tissue • supports obliteration of fistula tract FDA UDI
- Model / Reference
- Proctology FDA UDI
- Description
- The Fistula Brush can be used for probing of the fistula tract and for debridement before using the OTSC Proctology • it is used to clean the fistula tract and remove granulation tissue • supports obliteration of fistula tract FDA UDI
Identifiers
- Catalog Number
- 200.62 FDA UDI
- Primary DI / UDI-DI
- 04260206310631 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- General-purpose cytology brush FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose cytology brush
Fistula Brush by Ovesco Endoscopy AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose cytology brush.
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- Hobbs Nasal Cytology Brush — HOBBS MEDICAL, INC. · Class I
- StatLab — Yancheng Huida Medical Instruments Co., Ltd. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ovesco Endoscopy AG
Sources (1)
- FDA UDI 8d52cd84-a475-4682-896a-78dede861832 36 fields · synced Jun 7, 2026