Duns Number:690677802
Device Description: LawtonElite Atraumatic Malleable Suction Tube 11.5 cm WL, 5Fr
Catalog Number
07-871-10
Brand Name
LawtonElite Atraumatic Malleable Suction Tube
Version/Model Number
07-871-10
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
-
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
f199d01a-0a01-4447-9f06-b0ca3cc67c19
Public Version Date
January 03, 2022
Public Version Number
1
DI Record Publish Date
December 24, 2021
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 | 696 |
2 | A medical device with a moderate to high risk that requires special controls. | 566 |