FDA UDI
In Commercial Distribution
🇺🇸 United States
Vissard 3D, linear polarized
DI: 04049584022011
·
Model: 16030
·
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Vissard 3D, linear polarized
- Primary DI
- 04049584022011
- Version / Model
- 16030
- Company Name
- OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
- Labeler DUNS
- 317138956
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-01
- Public Version
- 1
- Public Version Date
- 2022-12-09
- Public Version Status
- New
- Public Device Record Key
- aa35645e-4351-4ddd-adbf-8146a90a8d75
Device Description
Vissard 3D, linear polarized
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 |
|---|---|---|---|---|
| HLG | Pupillometer, Ac-Powered | Ophthalmic | 886.1700 | 1 |
| HOX | Chart, Visual Acuity | Ophthalmic | 886.1150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36380 | Visual acuity light box | A mains electricity (AC-powered) light viewing box that uses a translucent version of the ophthalmic chart (Snellen chart) imprinted with block letters (optotypes) and/or other symbols (e.g., LEA symbols for children who can not read) in gradually decreasing sizes used for testing visual acuity. The letters/symbols are identified according to distances at which they are ordinarily visible (normally 6 metres or 20 feet) and are combined in a box where the individual letters or symbols are selected and high-lighted by the optician/doctor with background electrical lighting. This device is typically mounted on a wall of the optician/doctor's examination room/office. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049584022011 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 55 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal