Duns Number:017283879
Device Description: The Shaver 4mm Single Use Double Serrated Straight Blade is used with the Shaver System. The Shaver 4mm Single Use Double Serrated Straight Blade is used with the Shaver System. The blade is for single use and is supplied sterile. The Shaver System shapes bone and resects soft and hard tissues in the areas of otorhinolaryngology.
Catalog Number
-
Brand Name
Shaver Blade 4mm Single Use Double Serrated Straight
Version/Model Number
SSB-12400-1, SSB-12400-5
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
EQJ
Product Code Name
Bur, Ear, Nose And Throat
Public Device Record Key
c0c45c3f-3d72-44cd-9340-7c939bc70fb3
Public Version Date
October 05, 2020
Public Version Number
1
DI Record Publish Date
September 25, 2020
Package DI Number
10857326005786
Quantity per Package
1
Contains DI Package
00857326005789
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 |