Identity
- Trade Name
- LIN 50MHz Probe FDA UDI
- Generic Name
- Ophthalmic ultrasound imaging transducer FDA UDI
- Device Name
- 50 MHz probe reveals what you can not see with OCT alone, enabling the operator to visualize the structures located behind the iris such as ciliary bodies, the processes and lens zonules. Linear scanning offers the greatest signal intensity, providing superior anterior chamber image quality as the probe is always perpendicular with the tissue interface of interest. FDA UDI
- Model / Reference
- BHF-50LIN AVISO FDA UDI
- Description
- 50 MHz probe reveals what you can not see with OCT alone, enabling the operator to visualize the structures located behind the iris such as ciliary bodies, the processes and lens zonules. Linear scanning offers the greatest signal intensity, providing superior anterior chamber image quality as the probe is always perpendicular with the tissue interface of interest. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700542625088 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Ophthalmic ultrasound imaging transducer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic ultrasound imaging transducer
LIN 50MHz Probe by Quantel Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- UBM 35 MHz Transducer — DGH Technology, Inc. · Class II
- UBM Probe — DGH Technology, Inc. · Class II
- UBM 50 MHz Transducer — DGH Technology, Inc. · Class II
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
- Quantel Medical
Sources (1)
- FDA UDI 28481fc0-36cd-4344-bb7b-7cdb378565db 34 fields · synced Jun 8, 2026