Duns Number:544313588
Device Description: Rocket 8Fg Thoracentesis Drainage Kit
Catalog Number
R51554-08-PK
Brand Name
Rocket
Version/Model Number
R51554-08-PK
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"
Yes
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
-
Product Code Name
-
Public Device Record Key
d4f61d92-27da-4501-8582-a50f90499d0c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 19, 2016
Package DI Number
05055270972286
Quantity per Package
5
Contains DI Package
05055270972262
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |