Duns Number:203061833
Catalog Number
-
Brand Name
Trackable Suction - Tube 12-L-30
Version/Model Number
SYN-0653
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
GCX
Product Code Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Public Device Record Key
af39768a-f38e-4199-9e20-1fae048d27c6
Public Version Date
April 03, 2018
Public Version Number
3
DI Record Publish Date
February 28, 2017
Package DI Number
10670082000211
Quantity per Package
3
Contains DI Package
00670082000214
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 36 |