Duns Number:076603380
Device Description: Hood Tracheal Stoma Button
Catalog Number
-
Brand Name
Straight Stoma Stent
Version/Model Number
SS-1127
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
Yes
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
K882430
Product Code
BTO
Product Code Name
Tube, Tracheostomy (W/Wo Connector)
Public Device Record Key
baf3c93c-4b8f-4fe9-b565-0a27da9aae07
Public Version Date
June 05, 2020
Public Version Number
4
DI Record Publish Date
April 14, 2016
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 | 12 |
2 | A medical device with a moderate to high risk that requires special controls. | 340 |
U | Unclassified | 6 |