FDA UDI
In Commercial Distribution
🇺🇸 United States
UBM Probe
DI: 00857377006148
·
Model: DGH1500
·
DGH TECHNOLOGY INC.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- UBM Probe
- Primary DI
- 00857377006148
- Version / Model
- DGH1500
- Company Name
- DGH TECHNOLOGY INC.
- Labeler DUNS
- 057188807
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-05
- Public Version
- 4
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 783cc3ef-5d89-468a-8702-3b4a397acbe9
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36982 | Ophthalmic ultrasound imaging transducer | An ultrasound imaging transducer that is a hand-held device moved over the intact surface of a patient's eye during imaging applications involving the examination of the lens. It may include single or multiple element transducer assembly configurations that convert electric voltages into an ultrasound beam. Typically used with coupling gels to ensure adequate contact with the patient's eye it steers, focuses and detects the ultrasound beam and resulting echoes mechanically or electronically. This group of devices typically includes ultrasound imaging transducers used with A-mode scanning capabilities. This is a reusable device. | No | Active |
| 11389 | Ophthalmic ultrasound imaging system | An assembly of mains electricity (AC-powered) devices designed for ophthalmic imaging procedures. It includes software that supports a variety of static and real-time eye and orbital imaging applications including physical measurement and oncology related treatment. It will generate ultrasound pulses, direct them to a target area, detect the resulting ultrasound echoes, and process the resulting information producing and displaying static or dynamic two- or three-dimensional (3-D) images. This GMDN code includes ultrasound imaging systems with, e.g., A-mode, B-mode, Doppler, colour Doppler (CD), M-mode, and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857377006148 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171301 | 000 |