Duns Number:198227881
Device Description: Welch Allyn SureSight Autorefractor; Automatically screens for common vision problems, inc Welch Allyn SureSight Autorefractor; Automatically screens for common vision problems, including near and farsightedness (myopia/hyperopia), astigmatism (asymmetrical focus), and anisometropia (unequal power between eyes); Degree in Axis Readings, Charging Base, Thermal Printer, Storage Case; 230 V, 50 Hz AC, Lithium-Ion (#72420) Battery; IEC Plug
Catalog Number
14012
Brand Name
Welch Allyn, Inc.
Version/Model Number
901029
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HKO
Product Code Name
Refractometer, ophthalmic
Public Device Record Key
cb51608c-1da9-4bb3-a9b2-44229f0a46ae
Public Version Date
June 25, 2018
Public Version Number
3
DI Record Publish Date
December 05, 2017
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 | 374 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4080 |
| 3 | A medical device with high risk that requires premarket approval | 1 |