Duns Number:198227881
Device Description: Welch Allyn Power Supply Set for RetinaVue 700 Imager; 100-240 V, 50-60 Hz AC, IEC Plug Ty Welch Allyn Power Supply Set for RetinaVue 700 Imager; 100-240 V, 50-60 Hz AC, IEC Plug Type-B, -C, -G, and -I
Catalog Number
728099
Brand Name
Welch Allyn, Inc.
Version/Model Number
901122
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
d0893b6b-df24-467b-851f-6ceb8980695b
Public Version Date
June 28, 2022
Public Version Number
6
DI Record Publish Date
August 07, 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 | 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 |