Identity
- Trade Name
- Accu-Beam Mount - 65mm Zeiss EUDAMEDAccu-Beam FDA UDI
- Generic Name
- Laser adaptor FDA UDI
- Device Name
- Accu-Beam CO₂ Laser Accessories EUDAMEDZeiss Microscope (65mm objective)/OPMI I/OPMI II/Topcon OMS 70 mount for micromanipulators. FDA UDI
- Model / Reference
- 7029 EUDAMEDFDA UDI
- Description
- Zeiss Microscope (65mm objective)/OPMI I/OPMI II/Topcon OMS 70 mount for micromanipulators. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B17770290 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B177015Q EUDAMED
- 510(k) Number
- K864378 FDA UDI
- FDA Product Code
- HHR FDA UDI
- EMDN Code
- Z12011099 LASER SURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Laser adaptor FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4550 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Laser adaptor
Accu-Beam by Transamerican Technologies International — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Laser adaptor.
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Cleared under the same submission
K864378 also covers:
- Accu-Beam — Transamerican Technologies International
- Accu-Beam — Transamerican Technologies International
- Accu-Beam — Transamerican Technologies International
- Accu-Beam — Transamerican Technologies International
- Accu-Beam — Transamerican Technologies International
- Accu-Beam — Transamerican Technologies International
- Accu-Beam — Transamerican Technologies International
- Accu-Beam — Transamerican Technologies International
- Accu-Beam — Transamerican Technologies International
- Accu-Beam — Transamerican Technologies International
- Accu-Beam — Transamerican Technologies International
- Accu-Beam — Transamerican Technologies International
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Transamerican Technologies International
Sources (2)
- FDA UDI 107b7e53-1f81-4667-ad2c-ab1290f645e4 34 fields · synced Jul 26, 2026
- EUDAMED 739872f4-b190-42a4-a7a3-b77c67a8db93 61 fields · synced Jul 26, 2026