Duns Number:079641356
Device Description: Symmetry® Spatula, Davis Brain, 5/8 in, Insulated, 7 in, 177 mm
Catalog Number
22-0063I
Brand Name
Symmetry Surgical
Version/Model Number
22-0063I
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
GAF
Product Code Name
Spatula, Surgical, General & Plastic Surgery
Public Device Record Key
f53fe596-545b-4136-91ac-017f300a9725
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 11, 2017
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 |