Duns Number:198227881
Device Description: RETINAVUE700 IMAGER US
Catalog Number
RV700 B
Brand Name
Welch Allyn, Inc.
Version/Model Number
901124
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)
Yes
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
40feb177-5869-4034-ba84-86664c763eaf
Public Version Date
September 16, 2021
Public Version Number
5
DI Record Publish Date
August 07, 2019
Package DI Number
00732094323214
Quantity per Package
1
Contains DI Package
00732094299939
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |