Duns Number:025460908
Device Description: 10FR,FIRM,STYLET,ET TUBE
Catalog Number
DYNJSTY10
Brand Name
Medline
Version/Model Number
DYNJSTY10
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
a00c0e21-1aa2-4946-afdc-ef3d0f35ed39
Public Version Date
February 03, 2021
Public Version Number
1
DI Record Publish Date
January 26, 2021
Package DI Number
20888277400679
Quantity per Package
10
Contains DI Package
10888277400672
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |