Duns Number:106885259
Device Description: HK Tumescent Infiltration Cannula, (10cm) 4"-18 gauge, Single Use, Box of 10
Catalog Number
SU-IC18x10
Brand Name
HK Tumescent Infiltration Cannula, (10cm) 4"-18 gauge, Single Use, Box of 10
Version/Model Number
SU-IC18x10
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
Yes
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
c5cf73d2-562e-4644-b4c0-030b7755fbad
Public Version Date
November 30, 2020
Public Version Number
1
DI Record Publish Date
November 20, 2020
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 |