Duns Number:079641356
Device Description: 8" E Detachable Rongeur Lumbar 40 Degree Up 4.0 mm
Catalog Number
531630LED
Brand Name
Symmetry Rapidclean®
Version/Model Number
531630LED
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
HAE
Product Code Name
Rongeur, Manual
Public Device Record Key
7edf4b5b-64a3-491a-84c2-05bb3a014ec3
Public Version Date
July 12, 2019
Public Version Number
3
DI Record Publish Date
May 31, 2016
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 |