Duns Number:042823948
Device Description: VueLite ACMI Scope Adapter
Catalog Number
VL-AA
Brand Name
VueLite
Version/Model Number
G34311
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 04, 2019
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
Yes
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
NTN
Product Code Name
Led light source
Public Device Record Key
4e3a1c82-9183-411c-b58a-d07800e3cbd5
Public Version Date
February 05, 2019
Public Version Number
3
DI Record Publish Date
August 09, 2017
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 | 669 |
2 | A medical device with a moderate to high risk that requires special controls. | 8328 |
3 | A medical device with high risk that requires premarket approval | 370 |
U | Unclassified | 242 |