Identity
- Trade Name
- 8000 Series Reusable Channel Cleaning Brush FDA UDI
- Generic Name
- Endoscope cleaning brush, reusable FDA UDI
- Device Name
- Reusable Tapered Cleaning Brush. HIBC/UPN: M45381070 FDA UDI
- Model / Reference
- 8107 FDA UDI
- Description
- Reusable Tapered Cleaning Brush. HIBC/UPN: M45381070 FDA UDI
Identifiers
- Catalog Number
- 8107 FDA UDI
- Primary DI / UDI-DI
- 00666416110018 FDA UDI
- FDA Product Code
- MNL FDA UDI
- GMDN Term
- Endoscope cleaning brush, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
8000 Series Reusable Channel Cleaning Brush by Primed Instruments Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Primed Instruments Inc
Sources (1)
- FDA UDI 54f5d565-b523-42e6-a9d1-be96fb4e6157 38 fields · synced May 30, 2026