Duns Number:080375891
Device Description: 25ga ILM Elevator
Catalog Number
VS0300.25
Brand Name
25ga Edge Advantage ILM Elevator
Version/Model Number
VS0300.25
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
-
Product Code
HNQ
Product Code Name
Hook, Ophthalmic
Public Device Record Key
647c7c42-d2e3-4e93-9b5e-243f56af1cb0
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 30, 2016
Package DI Number
B384VS0300255
Quantity per Package
5
Contains DI Package
B384VS0300251
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 |