Duns Number:080375891
Device Description: 23ga Bending Laser Probe - Iridex Compatible
Catalog Number
VS0140.23I
Brand Name
23ga Bending Laser Probe - Iridex Compatible
Version/Model Number
VS0140.23I
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
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
K142830,K142830
Product Code
HQB
Product Code Name
Photocoagulator And Accessories
Public Device Record Key
44f19584-23a1-4bea-9295-fbbb3aa361ea
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
B384VS014023I5
Quantity per Package
10
Contains DI Package
B384VS014023I1
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 28 |
2 | A medical device with a moderate to high risk that requires special controls. | 23 |