Duns Number:314768383
Device Description: TRACHEOTEC VARIO, SIZE 5
Catalog Number
-
Brand Name
TRACHEOTEC
Version/Model Number
18560-05
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 12, 2021
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
BTO
Product Code Name
Tube, Tracheostomy (W/Wo Connector)
Public Device Record Key
d25d61e6-a1c5-4183-be80-e59d854a1959
Public Version Date
October 13, 2021
Public Version Number
4
DI Record Publish Date
September 17, 2015
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 575 |