Duns Number:079641356
Device Description: Quadlock® Bar, Limiting, 430 mm
Catalog Number
50-9040
Brand Name
Symmetry QUAD-LOCK™
Version/Model Number
50-9040
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
K120117
Product Code
KCT
Product Code Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Public Device Record Key
2e362cbc-adee-4a79-b2eb-2860d81db902
Public Version Date
July 08, 2021
Public Version Number
3
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 |