Duns Number:079999584
Device Description: TUBING SET, INFILTRATION,PVC
Catalog Number
130-0070
Brand Name
VASER
Version/Model Number
130-0070
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
MUU
Product Code Name
System, Suction, Lipoplasty
Public Device Record Key
ff6b0658-e635-4910-9fb3-961408d9b7ab
Public Version Date
April 05, 2019
Public Version Number
6
DI Record Publish Date
September 23, 2016
Package DI Number
10850608002596
Quantity per Package
10
Contains DI Package
00850608002599
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 61 |
2 | A medical device with a moderate to high risk that requires special controls. | 396 |