FDA UDI
In Commercial Distribution
🇺🇸 United States
KOWA nonmyd a-DIII
DI: 04987646800606
·
Model: K9L58K
·
KOWA COMPANY,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KOWA nonmyd a-DIII
- Primary DI
- 04987646800606
- Version / Model
- K9L58K
- Company Name
- KOWA COMPANY,LTD.
- Labeler DUNS
- 692281073
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 903a6991-7b9e-41ed-a21d-4edd2505845b
Device Description
KOWA nonmyd a-DIII, fundus camera, is intended for use with retinal image capturing without mydriatic. The retinal image can be stored to an image filing drive 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 | 04987646800606 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082767 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 462 | Millimeter | |
| Depth | 505 | Millimeter | |
| Width | 310 | Millimeter | |
| Weight | 22 | Kilogram |
Storage Conditions
- Type
- Handling 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 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity