Duns Number:071125835
Catalog Number
-
Brand Name
Digital High Mag®, Purple
Version/Model Number
VDGTLHM-PE
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HJL
Product Code Name
Lens, Condensing, Diagnostic
Public Device Record Key
9c83bc7b-7983-4664-97c6-b62c0468f5c4
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
September 25, 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 | 168 |
2 | A medical device with a moderate to high risk that requires special controls. | 92 |