Duns Number:175697908
Device Description: The Invuity Eigr Saber Waveguide with Yankauer is intended to deliver illumination from a The Invuity Eigr Saber Waveguide with Yankauer is intended to deliver illumination from a high intensity light source and to aspirate from the surgical site.
Catalog Number
ES2Y
Brand Name
Eigr™ Saber Waveguide
Version/Model Number
Yankauer, Fin Tip
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"
Yes
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
JOL
Product Code Name
Catheter And Tip, Suction
Public Device Record Key
8b593c78-e1b8-4739-9423-5d5217e97def
Public Version Date
April 24, 2020
Public Version Number
5
DI Record Publish Date
July 12, 2016
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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 28 |