Duns Number:017283879
Device Description: The Shaver System Irrigation Line is an accessory to the Shaver System. The Shaver System The Shaver System Irrigation Line is an accessory to the Shaver System. The Shaver System shapes bone and resects soft and hard tissues in the areas of otorhinolaryngology.
Catalog Number
-
Brand Name
Shaver System Irrigation Line
Version/Model Number
SSA-107
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GBX
Product Code Name
Catheter, Irrigation
Public Device Record Key
be489948-26a8-4dab-a01e-4eac0ce61831
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
September 24, 2020
Package DI Number
10857326005847
Quantity per Package
10
Contains DI Package
00857326005840
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |