Duns Number:688154202
Device Description: Digital Refractor system is a computerized auto refractor used for subjective refraction b Digital Refractor system is a computerized auto refractor used for subjective refraction by regarding the patient’s accommodation power and facilities.
Catalog Number
HDR-9000
Brand Name
Digital Refractor HDR-9000
Version/Model Number
HDR-9000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HKN
Product Code Name
Refractor, Manual, Non-Powered, Including Phoropter
Public Device Record Key
66348225-37c3-4ddb-99ad-7744baf17b46
Public Version Date
December 21, 2020
Public Version Number
2
DI Record Publish Date
May 10, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |