FDA UDI
In Commercial Distribution
🇺🇸 United States
Sun Designe
DI: 00860008278852
·
Model: 52
·
John A Taber
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sun Designe
- Primary DI
- 00860008278852
- Version / Model
- 52
- Company Name
- John A Taber
- Labeler DUNS
- 134097091
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-09
- Public Version
- 1
- Public Version Date
- 2022-03-17
- Public Version Status
- New
- Public Device Record Key
- 223728be-5c8e-4db5-bcc6-4223421708bf
Device Description
Metal Magnifying Spectacle Frame Commonly Called Reading Glasses
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 |
|---|---|---|---|---|---|---|
| Primary | 00860008278852 | GS1 |