Duns Number:079641356
Device Description: Symmetry® Rongeur, Stille-Luer Bone, Straight, 17.0 mm, 10 1/4 in
Catalog Number
31-3027
Brand Name
Symmetry Surgical®
Version/Model Number
31-3027
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
K081651
Product Code
HAE
Product Code Name
Rongeur, Manual
Public Device Record Key
e6f8a2d6-6f03-44eb-9a04-2f17d62a5e35
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
August 28, 2018
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 |