FDA UDI
In Commercial Distribution
🇺🇸 United States
Twilight
DI: 00860014752704
·
Model: V0001P
·
EVOQ TECHNOLOGIES CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Twilight
- Primary DI
- 00860014752704
- Version / Model
- V0001P
- Catalog Number
- TWL-0001
- Company Name
- EVOQ TECHNOLOGIES CORP.
- Labeler DUNS
- 145199610
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-30
- Public Version
- 1
- Public Version Date
- 2026-01-07
- Public Version Status
- New
- Public Device Record Key
- 7dc1181e-fafb-48a5-9a59-38cc7718eb80
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
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Primary | 00860014752704 | GS1 |
Customer Contacts
- Phone
- 8165295712
- [email protected]