Duns Number:167450993
Device Description: COLEMAN Multi-Hole Aspiration Cannula 12ga x 15cm
Catalog Number
COL-H1215
Brand Name
COLEMAN Multi-Hole Aspiration Cannula 12ga x 15cm
Version/Model Number
COL-H1215
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
K981172
Product Code
MUU
Product Code Name
System, suction, lipoplasty
Public Device Record Key
461d0dbd-9dc9-4aa2-a9a8-03fdb2014533
Public Version Date
February 21, 2019
Public Version Number
4
DI Record Publish Date
September 23, 2016
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 | 17 |
2 | A medical device with a moderate to high risk that requires special controls. | 128 |
3 | A medical device with high risk that requires premarket approval | 545 |
U | Unclassified | 514 |