Identity
- Trade Name
- Accu-Beam FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, reusable FDA UDI
- Device Name
- Re-usable fiberoptic handpiece for CO2 lasers. 230mm, 35 degree bend, spatula tip. FDA UDI
- Model / Reference
- 096087 FDA UDI
- Description
- Re-usable fiberoptic handpiece for CO2 lasers. 230mm, 35 degree bend, spatula tip. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B1770960870 FDA UDI
- 510(k) Number
- K952006 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical laser system beam guide, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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
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
Moist Heat or Steam Sterilization FDA UDI
Category: General/multiple surgical laser system beam guide, reusable
Accu-Beam by Transamerican Technologies International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General/multiple surgical laser system beam guide, reusable.
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Cleared under the same submission
K952006 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 (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 |
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Manufacturer
- Manufacturer
- Transamerican Technologies International
Sources (1)
- FDA UDI f02636fd-1218-40ac-ba72-531e174aa153 34 fields · synced Jun 9, 2026