Duns Number:401968495
Device Description: Volk Pictor Prestige retinal set including Pictor Prestige camera and Pictor Prestige reti Volk Pictor Prestige retinal set including Pictor Prestige camera and Pictor Prestige retina module.
Catalog Number
-
Brand Name
Volk Pictor Prestige retinal set
Version/Model Number
60101813A
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
K180378
Product Code
HKI
Product Code Name
Camera, Ophthalmic, Ac-Powered
Public Device Record Key
995af045-3844-4eaf-a9e7-7f32ea2f9814
Public Version Date
November 23, 2021
Public Version Number
2
DI Record Publish Date
December 04, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |