FDA UDI
In Commercial Distribution
🇺🇸 United States
HMC-Anomaloskop (MR)
DI: 04049584006875
·
Model: 47700
·
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HMC-Anomaloskop (MR)
- Primary DI
- 04049584006875
- Version / Model
- 47700
- 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
- 85985592-1be5-44dc-b800-4153b925827e
Device Description
HMC-Anomaloskop (MR)
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 |
|---|---|---|---|---|
| HIW | Anomaloscope | Ophthalmic | 886.1070 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16342 | Anomaloscope | A mains electricity (AC-powered) ophthalmic instrument used to test a patient for abnormal red/green colour vision by differentiating the red/green colour vision defects. It typically consists of two different light sources, one that permits the mixing of proportions of red and green and the other is a standard yellow colour which can be brightness adjusted. These are viewed and subsequently matched by the patient and according to the match, red- versus green-blindness, dichromacy versus anomalous trichromacy, and the severity of colour deficiency can be established. This device may be connected to a computer with dedicated application software. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049584006875 | 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