FDA UDI
In Commercial Distribution
🇺🇸 United States
Diopsys®
DI: 00850514007046
·
Model: 6020-0002-00
·
DIOPSYS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Diopsys®
- Primary DI
- 00850514007046
- Version / Model
- 6020-0002-00
- Company Name
- DIOPSYS, INC.
- Labeler DUNS
- 009972345
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-27
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- b8033127-1a62-433e-aba1-69a6c00e8b96
Device Description
ERG Lid Electrodes, Pouch
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GWE | Stimulator, Photic, Evoked Response | Neurology | 882.1890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46568 | Vision electrophysiology analysis system | An assembly of mains electricity (AC-powered) devices that provides visual stimuli (e.g., patterns of light, images) to a patient to measure, record, and display visual electrophysiologic responses [e.g., electroretinogram (ERG), visual evoked potential (VEP), and electrooculogram (EOG)], typically as an aid in the diagnosis and management of visual disorders involving ocular electrophysiology (EP), e.g., glaucoma. It may involve the use of electrodes placed on the patient's face and eyes, or the use of other devices such as visual stimulation goggles. The system may be used to screen infants and pre-school children for visual disorders without dilation or sedation. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850514007046 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101763 | 000 |