Duns Number:239505063
Device Description: Frazier Suction 9fg 9cm
Catalog Number
9fgN140
Brand Name
Single Use Surgical Professional
Version/Model Number
9fgN140
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GCX
Product Code Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Public Device Record Key
3d555e9b-c430-4cda-9406-4ca619d90aee
Public Version Date
April 20, 2020
Public Version Number
4
DI Record Publish Date
August 09, 2016
Package DI Number
05055299100059
Quantity per Package
25
Contains DI Package
05055299100806
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |