Identity
- Trade Name
- Single Use Brush Biopsy Instrument FDA UDI
- Generic Name
- Flexible endoscopic cytology brush, single-use FDA UDI
- Device Name
- WATS Biopsy Instrument for Computer Assisted 3D Analysis FDA UDI
- Model / Reference
- TNL-80 FDA UDI
- Description
- WATS Biopsy Instrument for Computer Assisted 3D Analysis FDA UDI
Identifiers
- Catalog Number
- TNL-80 FDA UDI
- Primary DI / UDI-DI
- 00816207021706 FDA UDI
- FDA Product Code
- GEE FDA UDI
- GMDN Term
- Flexible endoscopic cytology brush, single-use 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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 80 Centimeter FDA UDI
Category: Flexible endoscopic cytology brush, single-use
Single Use Brush Biopsy Instrument by Endo-Therapeutics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible endoscopic cytology brush, single-use.
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
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- CONMED — Conmed Corporation · Class II
- Disposable Bronchial Cytology Brush — TeleMed Systems · Class II
- CONMED — Conmed Corporation · Class II
- CONMED — Conmed Corporation · Class I
- DISPOSABLE CYTOLOGY BRUSH — Olympus Medical Systems Corporation · Class II
- Gyrus ACMI — Gyrus Acmi, Inc. · Class II
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
- Endo-Therapeutics, Inc.
Sources (1)
- FDA UDI 7e36ea48-4365-41fb-b124-36127302fbac 37 fields · synced Jun 8, 2026