FDA UDI
In Commercial Distribution
🇺🇸 United States
AUTO REF/KERATOMETER
DI: 04987669100738
·
Model: ARK-1s
·
NIDEK CO.,LTD.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AUTO REF/KERATOMETER
- Primary DI
- 04987669100738
- Version / Model
- ARK-1s
- Company Name
- NIDEK CO.,LTD.
- Labeler DUNS
- 690635461
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-10
- Public Version
- 5
- Public Version Date
- 2020-12-21
- Public Version Status
- Update
- Public Device Record Key
- 830086bc-8c03-4d1e-841a-99e48a703c2e
Device Description
The NIDEK AUTO REF/KERATOMETER ARK-1s measures spherical, cylindrical refractive errors, and cylinder axis from the refractive status of the patient’s eye. In addition, subjective test is performed with the built-in charts and lenses for subjective measurement. The keratometer measures the corneal curvature radius (corneal refractive power), principal meridian directions, and corneal cylindrical power.
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
- 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 |
|---|---|---|---|---|
| HLQ | Keratoscope, Ac-Powered | Ophthalmic | 886.1350 | 1 |
| HKO | Refractometer, Ophthalmic | Ophthalmic | 886.1760 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12811 | Bench-top keratometer | A bench-top, mains electricity (AC-powered) ophthalmic instrument designed to measure the curvature of the anterior surface of the cornea, particularly for determining the presence, extent, and axis of astigmatism (an error of refraction in the eye due to the cornea being unequally curved in different directions, so that rays of light in different meridians cannot be brought to focus together on the retina). It actually measures the radius of curvature in millimetres but typically displays it in dioptres. It is used mainly for contact lens fitting and for intraocular lens power determination prior to cataract surgery. This device is also known as an ophthalmometer. | No | Active |
| 36386 | Automated ophthalmic refractometer | An electrically-powered, ophthalmic device designed to be used by a healthcare professional to objectively measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) by measuring how light is changed when it enters the patient's eye(s). The device emits light into the eye and detects the light reflection which is measured for sphere, cylinder, axis and/or high order aberration measurements, typically measured in dioptres (the reciprocal of the focal length of the lens expressed in metres). Also known as an aberrometer, the device uses this information to automatically calculate the lens prescription needed to correct the patient's vision. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04987669100738 | GS1 |
Customer Contacts
- Phone
- 1-800-223-9044
- [email protected]