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Single Use Brush Biopsy Instrument
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref EGD-160-006Ref TNE-110Ref EGD-230-006
Identity
- Trade Name
- Single Use Brush Biopsy Instrument FDA UDI
- Generic Name
- Flexible endoscopic cytology brush, single-use FDA UDI
- Device Name
- Biopsy Brush EUDAMEDWATS Biopsy Instrument for Computer Assisted 3D Analysis FDA UDI
- Model / Reference
- EGD-160-006 EUDAMEDFDA UDIEGD-230-006 EUDAMEDFDA UDITNE-110 EUDAMEDFDA UDI
- Description
- WATS Biopsy Instrument for Computer Assisted 3D Analysis FDA UDI
Identifiers
- Catalog Number
- EGD-160-006 FDA UDIEGD-230-006 FDA UDITNE-110 FDA UDI
- Primary DI / UDI-DI
- 00816207021027 EUDAMEDFDA UDI00816207021041 EUDAMEDFDA UDI00816207021690 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816207021027 EUDAMEDB-00816207021690 EUDAMEDB-00816207021041 EUDAMED
- FDA Product Code
- GEE FDA UDI
- EMDN Code
- G03080399 GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BRUSHES - OTHER EUDAMED
- GMDN Term
- Flexible endoscopic cytology brush, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Malta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 — 160 Centimeter FDA UDILength — 230 Centimeter FDA UDILength — 110 Centimeter FDA UDI
Category: Flexible endoscopic cytology brush, single-use
Single Use Brush Biopsy Instrument by Endo-Therapeutics, Inc. — Class I — 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
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Endo-Therapeutics, Inc.
Sources (6)
- FDA UDI 82ca9e85-b07a-4b7c-a143-aeeac9f2d633 37 fields · synced Jul 21, 2026
- FDA UDI 9d70b870-f069-40af-80b7-0cc8c872aec8 37 fields · synced May 30, 2026
- FDA UDI 47a19c8c-c0c9-4ea5-94ab-6e44b98c9c43 37 fields · synced May 30, 2026
- EUDAMED 64b4816f-6b86-4297-8a50-98cb73297043 61 fields · synced Jul 12, 2026
- EUDAMED ef32634d-6d9e-4cb6-83b3-d9c8ba0d5f54 61 fields · synced Jul 18, 2026
- EUDAMED 50e83cba-0ba9-4eca-a738-3a6e26fa656f 61 fields · synced Jul 21, 2026