Duns Number:017283879
Device Description: The Shaver System Handpiece is a component of the Shaver System. The Shaver System shapes The Shaver System Handpiece is a component of 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 Handpiece
Version/Model Number
SSA-104
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
-
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
ERL
Product Code Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Public Device Record Key
a82f6d79-994b-470e-92a0-73d1a5164082
Public Version Date
October 02, 2020
Public Version Number
1
DI Record Publish Date
September 24, 2020
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |