FDA UDI
In Commercial Distribution
🇺🇸 United States
MAX STUDIO
DI: 00802807356294
·
Model: 4296 DOPP KIT
·
Evolutioneyes, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- MAX STUDIO
- Primary DI
- 00802807356294
- Version / Model
- 4296 DOPP KIT
- Company Name
- Evolutioneyes, Inc.
- Labeler DUNS
- 825224459
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2024-01-11
- Public Version
- 1
- Public Version Date
- 2024-01-19
- Public Version Status
- New
- Public Device Record Key
- 5c2cb69f-3dfe-4d74-8adb-12555f743907
Device Description
READER 2 PACK
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
- 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 |
|---|---|---|---|---|
| HOI | Spectacle, magnifying | Ophthalmic | 886.5840 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42832 | Magnifying spectacles | A device that consists of a spectacle frame with convex lenses intended to enlarge text/images for a visually impaired patient/person. It is made of plastic material or glass within a plastic or metal frame. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00802807320240 | GS1 | ||||
| Primary | 00802807356294 | GS1 |