Duns Number:079641356
Device Description: Symmetry® Rongeur, IVD, Curved Up, 2X6 mm Cup, 9 in, 228 mm
Catalog Number
SP00625-7
Brand Name
Symmetry Surgical®
Version/Model Number
SP00625-7
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
04603b2d-2f21-4882-95f3-29c56867d92f
Public Version Date
July 12, 2019
Public Version Number
2
DI Record Publish Date
September 25, 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 |