FDA UDI
In Commercial Distribution
🇺🇸 United States
Pachmate 2
DI: 00857377006001
·
Model: DGH 55B
·
DGH TECHNOLOGY INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pachmate 2
- Primary DI
- 00857377006001
- Version / Model
- DGH 55B
- Company Name
- DGH TECHNOLOGY INC.
- Labeler DUNS
- 057188807
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-11
- Public Version
- 4
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 233f0f83-74c7-4819-b67c-0f8cfb590808
Device Description
The DGH 55B is a Handheld Ultrasonic Pachymeter. It is a hand-held, battery-powered electronic medical device that uses ultrasonic pulse technology to measure the thickness of the human cornea.
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 |
|---|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16330 | Ultrasound pachymeter | A mains electricity (AC-powered), ophthalmic device designed to use ultrasound to measure the thickness of the cornea, and may in addition be designed to measure axial length and anterior chamber depth. A small ultrasound probe(s) that is connected to this device is placed directly onto the cornea to make the measurements which are recorded and displayed by the pachymeter. The data is used to evaluate refractive eye surgery [e.g., laser assisted in situ keratomileusis (LASIK) treatment], evaluate ocular measurements for calculating intraocular lens power, monitor epithelium regrowth, and for other ophthalmic measurement evaluations. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857377006001 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K033385 | 000 |