Duns Number:198227881
Device Description: Welch Allyn VS100 Spot Vision Screener with Wrist Strap and 8' (2.5m) US Power Cord (2.5A, Welch Allyn VS100 Spot Vision Screener with Wrist Strap and 8' (2.5m) US Power Cord (2.5A, 125V) (Carrying Case not Included)
Catalog Number
VS100-B
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
a2bdd4e5-6205-402b-bea6-d3420af4a295
Public Version Date
September 24, 2019
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 |