FDA UDI
In Commercial Distribution
🇺🇸 United States
KOWA nonmyd WX
DI: 04987646806592
·
Model: K9L57FK
·
KOWA COMPANY,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KOWA nonmyd WX
- Primary DI
- 04987646806592
- Version / Model
- K9L57FK
- Company Name
- KOWA COMPANY,LTD.
- Labeler DUNS
- 692281073
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- fd583fb5-791b-44b6-9903-e1165e2c7a61
Device Description
KOWA nonmyd WX is intended for use with plane and stereo retinal image capturing without mydriatic. The retina image can be stored to an image filing derive through serial interface.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| HKI | Camera, Ophthalmic, Ac-Powered | Ophthalmic | 886.1120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10551 | Ophthalmic fundus camera | An electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04987646806592 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101628 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 548 | Millimeter | |
| Depth | 504 | Millimeter | |
| Width | 310 | Millimeter | |
| Weight | 21 | Kilogram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -15 – 55 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 35 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 90 Percent (%) Relative Humidity