Identity
- Trade Name
- UBM Probe FDA UDI
- Generic Name
- Ophthalmic ultrasound imaging transducer FDA UDI
- Device Name
- The DGH1500 is a single-element mechanical sector UBM probe. This probe connects to the Scanmate Flex USB interface module, which is, in turn, connected via a USB cable to a PC running the DGH Scanmate software. FDA UDI
- Model / Reference
- DGH1500 FDA UDI
- Description
- The DGH1500 is a single-element mechanical sector UBM probe. This probe connects to the Scanmate Flex USB interface module, which is, in turn, connected via a USB cable to a PC running the DGH Scanmate software. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857377006148 FDA UDI
- 510(k) Number
- K171301 FDA UDI
- FDA Product Code
- ITX FDA UDIIYO FDA UDI
- GMDN Term
- Ophthalmic ultrasound imaging transducer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1560 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
Yes
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 systemOphthalmic ultrasound imaging transducer
UBM Probe by DGH Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- DGH Technology, Inc.
Sources (1)
- FDA UDI 783cc3ef-5d89-468a-8702-3b4a397acbe9 34 fields · synced Jun 15, 2026