Identity
- Trade Name
- Accu-Beam FDA UDI
- Generic Name
- Laser adaptor FDA UDI
- Device Name
- Sharplan Quick Disconnect (1040, 1060, and 1100) CO2 Laser Thread Adapter. FDA UDI
- Model / Reference
- 1101 FDA UDI
- Description
- Sharplan Quick Disconnect (1040, 1060, and 1100) CO2 Laser Thread Adapter. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B17711010 FDA UDI
- 510(k) Number
- K864378 FDA UDI
- FDA Product Code
- HHR FDA UDI
- GMDN Term
- Laser adaptor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4550 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
Category: Laser adaptor
Accu-Beam by Transamerican Technologies International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- LightScalpel — LIGHTSCALPEL INC · Class II
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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 (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 35dbd1ec-caca-4135-865e-59505b700b3a 34 fields · synced Jun 9, 2026