Duns Number:239403863
Device Description: The Tube Organiser is used to secure and organize tubing, cables & leads. The use of the The Tube Organiser is used to secure and organize tubing, cables & leads. The use of the Tube organiser helps ensure the surgical work area is kept free of the potential of trip and entanglement hazards associated with loose tubing during procedures, and aids prevention of kinking and possible occlusion.
Catalog Number
PS5100
Brand Name
Tube Organiser
Version/Model Number
PS5100
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYX
Product Code Name
Tubing, Pressure And Accessories
Public Device Record Key
57f7ce63-457c-4ab8-88e6-9901c6ae9dd9
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 17, 2016
Package DI Number
55051223004429
Quantity per Package
100
Contains DI Package
35051223004425
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shipping carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 20 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 128 |