Duns Number:003152968
Device Description: Lightbox Umbilical is intended for use in peripheral vascular procedures in conjunction wi Lightbox Umbilical is intended for use in peripheral vascular procedures in conjunction with a compatible Avinger product.
Catalog Number
U100
Brand Name
Lightbox Umbilical
Version/Model Number
U100
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
Yes
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
PDU
Product Code Name
Catheter For Crossing Total Occlusions
Public Device Record Key
e6c03753-3fc1-4d86-af3e-09840429266d
Public Version Date
March 29, 2019
Public Version Number
1
DI Record Publish Date
March 21, 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |