Duns Number:106885259
Device Description: HK Single Port Finesse Microcannula, 2.75"-18 gauge
Catalog Number
HK18FSP7
Brand Name
HK Single Port Finesse Microcannula, 2.75"-18 gauge
Version/Model Number
HK18FSP7
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
GEA
Product Code Name
Cannula, Surgical, General & Plastic Surgery
Public Device Record Key
c20669c5-269d-4815-83e2-f181f8507648
Public Version Date
February 21, 2019
Public Version Number
3
DI Record Publish Date
June 25, 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 | 77 |
2 | A medical device with a moderate to high risk that requires special controls. | 12 |