Duns Number:106885259
Device Description: HK Monty Infiltration Cannula, 6"-16 gauge Full Monty
Catalog Number
IC16FM15
Brand Name
HK Monty Infiltration Cannula, 6"-16 gauge Full Monty
Version/Model Number
IC16FM15
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
07022d71-9459-4c6c-b6c2-cc98418b94bc
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 |