Duns Number:002348191
Device Description: Flexi-slip Endotracheal Tube Stylet with Soft Distal Tip
Catalog Number
502503
Brand Name
RUSCH
Version/Model Number
IPN044647
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)
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
8364b29f-745b-4fc6-8685-4b66808b3c39
Public Version Date
May 10, 2022
Public Version Number
2
DI Record Publish Date
September 15, 2018
Package DI Number
44026704543661
Quantity per Package
5
Contains DI Package
24026704543667
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |