Duns Number:835465063
Device Description: STYLET 8330400 TUBE-STAT ORO-TRACH ROHS
Catalog Number
-
Brand Name
TUBE-STAT®
Version/Model Number
8330400
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"
-
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
K843490
Product Code
BSR
Product Code Name
STYLET, TRACHEAL TUBE
Public Device Record Key
1c6b65ed-95a7-4d40-bdbc-ddd3444d4b2d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 01, 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 | 665 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1575 |
| 3 | A medical device with high risk that requires premarket approval | 6 |
| U | Unclassified | 10 |