Duns Number:079641356
Device Description: Symmetry® Impactor, Central Canal, Tip Oriented 30° From Vertical, 1/2 in Tip Length, 7/32 Symmetry® Impactor, Central Canal, Tip Oriented 30° From Vertical, 1/2 in Tip Length, 7/32 in Wide Tip, 8 3/4 in
Catalog Number
46-3008
Brand Name
Symmetry Surgical®
Version/Model Number
46-3008
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 01, 9999
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
HWA
Product Code Name
Impactor
Public Device Record Key
4b0662af-91e6-46c0-b04a-1b6a05ce03e1
Public Version Date
September 26, 2022
Public Version Number
1
DI Record Publish Date
September 16, 2022
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 | 7981 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3309 |