Duns Number:041956211
Device Description: Guidewire, NiTi Trocar, Non-Threaded 560mm
Catalog Number
10-NTN-0560
Brand Name
Cosmolock
Version/Model Number
10-NTN-0560
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GDF
Product Code Name
Guide, Needle, Surgical
Public Device Record Key
77923bc0-f2f1-434f-8d9f-e86f730885a9
Public Version Date
June 29, 2022
Public Version Number
1
DI Record Publish Date
June 21, 2022
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 | 1286 |
2 | A medical device with a moderate to high risk that requires special controls. | 1900 |