FDA UDI
In Commercial Distribution
🇺🇸 United States
AdaptDx Pro USB-C Headset Cable
DI: 00850006785070
·
Model: 10388
·
MACULOGIX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AdaptDx Pro USB-C Headset Cable
- Primary DI
- 00850006785070
- Version / Model
- 10388
- Company Name
- MACULOGIX, INC.
- Labeler DUNS
- 962692179
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-27
- Public Version
- 1
- Public Version Date
- 2022-02-04
- Public Version Status
- New
- Public Device Record Key
- 1da3ca31-e67d-48ba-8cb1-cfb2b5c32483
Device Description
This is a USB-C cable used to connect the AdaptDx Pro handheld controller with the AdaptDx Pro headset.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| OUM | Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation | Ophthalmic | 886.1050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10024 | Adaptometer | A mains electricity (AC-powered) ophthalmic device that provides a stimulating light source having various controlled intensities intended to measure the time required for retinal adaptation (regeneration of the visual purple) and the minimum light threshold. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850006785077 | GS1 | Shipping Box | 1 | In Commercial Distribution | |
| Primary | 00850006785070 | GS1 |