Duns Number:011560431
Device Description: ONETRAC LXS SUCTION, TAPER TIP, WITH BUILT IN RADIAL LIGHT SOURCE, SINGLE USE - STERILE
Catalog Number
C110220
Brand Name
ONETRAC LXS
Version/Model Number
C110220
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)
Yes
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
-
Product Code
JOL
Product Code Name
Catheter And Tip, Suction
Public Device Record Key
edb3d261-10ad-4e8f-8006-1545969c9d43
Public Version Date
April 25, 2022
Public Version Number
1
DI Record Publish Date
April 15, 2022
Package DI Number
M648C1102201
Quantity per Package
1
Contains DI Package
M648C1102200
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
unit box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |