Identity
- Trade Name
- 8000 Series Reusable Channel Cleaning Brush FDA UDI
- Generic Name
- Endoscope cleaning brush, reusable FDA UDI
- Device Name
- Suction Well Cleaning Brush. HIBC: M45388801 FDA UDI
- Model / Reference
- 8880 FDA UDI
- Description
- Suction Well Cleaning Brush. HIBC: M45388801 FDA UDI
Identifiers
- Catalog Number
- 8880 FDA UDI
- Primary DI / UDI-DI
- 00666416110100 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
- 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Endoscope cleaning brush, reusable
8000 Series Reusable Channel Cleaning Brush by Primed Instruments Inc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope cleaning brush, reusable.
- Urocare® Urinary & Ostomy Appliance Cleaning Brush 8" (20cm) — UROCARE PRODUCTS, INC. · Class I
- 8000 Series Reusable Channel Cleaning Brush — Primed Instruments Inc · Class I
- 8000 Series Reusable Channel Cleaning Brush — Primed Instruments Inc · Class I
- 8000 Series Reusable Channel Cleaning Brush — Primed Instruments Inc · Class I
- 8000 Series Reusable Channel Cleaning Brush — Primed Instruments Inc · Class I
- 8000 Series Reusable Channel Cleaning Brush — Primed Instruments Inc · Class I
- 8000 Series Reusable Channel Cleaning Brush — Primed Instruments Inc · Class I
- 8000 Series Reusable Channel Cleaning Brush — Primed Instruments Inc · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Primed Instruments Inc
Sources (2)
- FDA UDI 1f02dbe4-36ba-429c-8acb-186a8a49e5c2 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026