Duns Number:066087031
Device Description: Endotracheal Stylet, size= 10Fr, fits endotracheal tubes of sizes internal diameter 4-5 mm Endotracheal Stylet, size= 10Fr, fits endotracheal tubes of sizes internal diameter 4-5 mm.
Catalog Number
ES105
Brand Name
Endure
Version/Model Number
ES1051217
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BSR
Product Code Name
Stylet, Tracheal Tube
Public Device Record Key
5124acb8-23aa-4a58-a80e-86f9492d808c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 20, 2018
Package DI Number
B531ES1052
Quantity per Package
20
Contains DI Package
B531ES1051
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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |