Duns Number:007198742
Device Description: "437 Lowsley Tractor Curved 10.5 Inch"
Catalog Number
-
Brand Name
Curved Lowsley™ Tractor Single-Action, Stem Only 21.5 Fr (7.1mm) With
Version/Model Number
437
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
K012153
Product Code
KOB
Product Code Name
CATHETER, SUPRAPUBIC (AND ACCESSORIES)
Public Device Record Key
ff0945d2-f4dc-4540-b063-48aa081359fc
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 12, 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 | 899 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 4 |