Duns Number:198227881
Device Description: Welch Allyn RETeval-DR Electroretinograph including Disposable Sensor Strips (2 Packs of 5 Welch Allyn RETeval-DR Electroretinograph including Disposable Sensor Strips (2 Packs of 50 ea), Charging Dock, and USB Cable; Lithium-Ion Battery (#RETeval-ACC-02); 100-240 V, 50-60 Hz, IEC Plug Types A, G, E/F, and I; Multiple Languages
Catalog Number
RETEVAL-001
Brand Name
Welch Allyn, Inc.
Version/Model Number
901101
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
PJZ
Product Code Name
Camera, ophthalmic, general-use
Public Device Record Key
cc808e20-a847-4b78-b9f1-742719b89015
Public Version Date
March 27, 2020
Public Version Number
1
DI Record Publish Date
March 19, 2020
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 |