EndoTBrush Cytology Brush
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- EndoTBrush EUDAMEDEndoTBrush Cytology Brush FDA UDI
- Generic Name
- Flexible endoscopic cytology brush, single-use FDA UDI
- Device Name
- Cytology Brush EUDAMEDEndoscopic cytology brush FDA UDI
- Model / Reference
- ET1421 EUDAMEDFDA UDIET1423 EUDAMEDFDA UDIET1420 EUDAMEDFDA UDI
- Description
- Endoscopic cytology brush FDA UDI
Identifiers
- Catalog Number
- ET1421 FDA UDIET1423 FDA UDIET1420 FDA UDI
- Primary DI / UDI-DI
- 00816207020143 EUDAMEDFDA UDI00816207020167 EUDAMEDFDA UDI00816207020136 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816207020167 EUDAMEDB-00816207020136 EUDAMEDB-00816207020143 EUDAMED
- 510(k) Number
- K800966 FDA UDI
- FDA Product Code
- FDX FDA UDI
- EMDN Code
- G03080301 GASTROINTESTINAL CYTOLOGY, BRUSHES EUDAMED
- GMDN Term
- Flexible endoscopic cytology brush, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Malta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 150 Centimeter FDA UDIOuter Diameter — 1.7 Millimeter FDA UDILength — 220 Centimeter FDA UDIOuter Diameter — 2.4 Millimeter FDA UDILength — 110 Centimeter FDA UDI
Category: Flexible endoscopic cytology brush, single-use
EndoTBrush Cytology Brush by Endo-Therapeutics, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Flexible endoscopic cytology brush, single-use.
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- DISPOSABLE CYTOLOGY BRUSH — Olympus Medical Systems Corporation · Class II
- 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
Cleared under the same submission
K800966 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Endo-Therapeutics, Inc.
Sources (6)
- FDA UDI cd03e4f3-b9c1-467d-812a-1a646c775cdf 38 fields · synced Jul 31, 2026
- FDA UDI 818dc808-0802-4885-90c5-a5061274a1cc 38 fields · synced May 30, 2026
- FDA UDI 79cb41bc-f10a-4820-a5dd-546fc7a82cf3 38 fields · synced May 30, 2026
- EUDAMED d52bbe4b-6786-428b-9027-c1443e275b5a 61 fields · synced Jul 9, 2026
- EUDAMED f7d63730-8ece-4c98-80dd-596c49ddbb3c 61 fields · synced Jul 31, 2026
- EUDAMED 7e357214-e136-436c-a4c1-f1a027b1e88f 61 fields · synced Jul 31, 2026