Duns Number:656763489
Catalog Number
-
Brand Name
Silicone Penrose Drain Tube
Version/Model Number
2010-5405
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
GCD
Product Code Name
Connector, Catheter
Public Device Record Key
b2b8a0e4-c8f3-4058-9d97-9dc0b546d513
Public Version Date
December 23, 2021
Public Version Number
1
DI Record Publish Date
December 15, 2021
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 | 307 |
2 | A medical device with a moderate to high risk that requires special controls. | 3 |