Duns Number:080375891
Device Description: 27ga Curved Laser Probe - Alcon Compatible
Catalog Number
VS0120.27A
Brand Name
27ga Curved Laser Probe - Alcon Compatible
Version/Model Number
VS0120.27A
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"
-
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
K021696,K021696
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
2c4de015-1d3a-45b9-9dfa-339a8e2ad2f0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
B384VS012027A5
Quantity per Package
10
Contains DI Package
B384VS012027A1
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 |