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Accu-Beam Cleaning Brush 550mm
EUDAMEDFDA UDIClass I (EU MDR)
Ref AC-1069640-01
Identity
- Trade Name
- Accu-Beam Cleaning Brush 550mm EUDAMEDAccu-Beam FDA UDI
- Generic Name
- Surgical irrigation/aspiration handpiece, reusable FDA UDI
- Device Name
- Accu-Beam Fiber Optic Handpiece Accessories EUDAMEDCleaning Brush - 550mm x 1.524mm FDA UDI
- Model / Reference
- AC-1069640-01 EUDAMEDAC-1069640-1 FDA UDI
- Description
- Cleaning Brush - 550mm x 1.524mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- B177AC1069640010 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B17705AK2 EUDAMED
- 510(k) Number
- K910978 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- L80 SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIES EUDAMED
- GMDN Term
- Surgical irrigation/aspiration handpiece, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
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
Accu-Beam Cleaning Brush 550mm by Transamerican Technologies International — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B17705AK2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Transamerican Technologies International
- EUDAMED SRN
- US-MF-000007955
- Authorised Representative
- QNET B.V. NL-AR-000002695
Sources (2)
- EUDAMED df7f79d0-72d4-4bc5-98cf-436c17ad1acf 61 fields · synced Jun 18, 2026
- FDA UDI f5f97199-4fdd-457d-8418-2550bbcc9ee9 34 fields · synced May 30, 2026