Duns Number:079999584
Device Description: 4.6 mm Skin Port Plug
Catalog Number
130-0112
Brand Name
VASER
Version/Model Number
130-0112
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 09, 2017
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
f2ec5cc4-ab95-4eee-97aa-5b22a140fe98
Public Version Date
November 05, 2018
Public Version Number
5
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 | 61 |
2 | A medical device with a moderate to high risk that requires special controls. | 396 |