FDA UDI
In Commercial Distribution
🇺🇸 United States
Chart Projector CCP-3100
DI: 08800019600220
·
Model: CCP-3100
·
Huvitz Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Chart Projector CCP-3100
- Primary DI
- 08800019600220
- Version / Model
- CCP-3100
- Catalog Number
- CCP-3100
- Company Name
- Huvitz Co., Ltd.
- Labeler DUNS
- 688154202
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-10
- Public Version
- 1
- Public Version Date
- 2019-05-20
- Public Version Status
- New
- Public Device Record Key
- af2f93d2-5967-4ebf-adea-20f42c591e68
Device Description
chart projector is intended to be used to check eye optometry
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| HOS | Projector, Ophthalmic | Ophthalmic | 886.1680 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35922 | Visual acuity projector | A mains electricity (AC-powered) ophthalmic device intended to project an image on a screen to test visual acuity. The images typically include block letters (Snellen chart) and/or other symbols (e.g., recognizable objects used for children who cannot read) viewed in gradually decreasing size. They are typically identified according to the distance at which they are ordinarily visible (normally 6 metres or 20 feet). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800019600220 | GS1 |
Customer Contacts
- Phone
- +82314289100
- [email protected]