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Accu-Beam Fiber Optic Handpiece - 14ga, 11cm, malleable
EUDAMEDFDA UDIClass I (EU MDR)
Ref 9113B-14
Identity
- Trade Name
- Accu-Beam Fiber Optic Handpiece - 14ga, 11cm, malleable EUDAMEDAccu-Beam FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, reusable FDA UDI
- Device Name
- Accu-Beam Fiber Optic Handpieces EUDAMEDRe-usable fiberoptic handpiece for lasers. Malleable - 11cm, 14ga, ID 1.5mm. FDA UDI
- Model / Reference
- 9113B-14 EUDAMEDFDA UDI
- Description
- Re-usable fiberoptic handpiece for lasers. Malleable - 11cm, 14ga, ID 1.5mm. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B1779113B140 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B177055Y EUDAMED
- Direct Marketing DI
- B1779113B140 EUDAMED
- 510(k) Number
- K952006 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- L030199 GENERAL SURGERY SURGICAL CANNULAS AND HANDPIECES, REUSABLE - OTHER EUDAMED
- GMDN Term
- General/multiple surgical laser system beam guide, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 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
Yes
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 Fiber Optic Handpiece - 14ga, 11cm, malleable 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 | ++B177055Y | 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 3bb8f59b-e2a9-4646-88e5-7109e931eed7 61 fields · synced Oct 6, 2026
- FDA UDI 1bf31cfb-d7df-42ea-bd15-cd1c9e0b4c4c 34 fields · synced May 30, 2026