Duns Number:131855157
Device Description: Size: 10
Catalog Number
3310
Brand Name
Trach Tube Cleaning Brushes
Version/Model Number
3310
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
EPE
Product Code Name
Brush, Cleaning, Tracheal Tube
Public Device Record Key
8d61390d-3ca2-453c-9959-96c7ed5cc4dc
Public Version Date
October 10, 2022
Public Version Number
1
DI Record Publish Date
September 30, 2022
Package DI Number
34063107102708
Quantity per Package
10
Contains DI Package
14063107102704
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 | 121 |
2 | A medical device with a moderate to high risk that requires special controls. | 211 |
U | Unclassified | 1 |