Identity
- Trade Name
- Cook FDA UDI
- Generic Name
- Flexible endoscopic cytology brush, single-use FDA UDI
- Device Name
- Bronchial Brush Biopsy Set FDA UDI
- Model / Reference
- G03536 FDA UDI
- Description
- Bronchial Brush Biopsy Set FDA UDI
Identifiers
- Catalog Number
- TDHB-300 FDA UDI
- Primary DI / UDI-DI
- 00827002035362 FDA UDI
- FDA Product Code
- BTG FDA UDI
- GMDN Term
- Flexible endoscopic cytology brush, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4680 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: Flexible endoscopic cytology brush, single-use
Cook by Cook Incorporated — Class II — 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
- DISPOSABLE CYTOLOGY BRUSH — Olympus Medical Systems Corporation · Class II
- CONMED — Conmed Corporation · Class II
- EndoTBrush Cytology Brush — ENDO-THERAPEUTICS, INC. · 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
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI f4a30152-a4ef-46ae-b1b9-b34251d0364f 36 fields · synced Jun 8, 2026