Duns Number:016898496
Device Description: Bard LeFort Metal Sound, Threaded Tip, Stainless Steel 14 Fr.
Catalog Number
042614
Brand Name
Bard® LeFort Metal Sound
Version/Model Number
042614
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
FBX
Product Code Name
SOUND, URETHRAL, METAL OR PLASTIC
Public Device Record Key
05a48035-e844-4fa8-af99-02ffb7f59095
Public Version Date
February 06, 2020
Public Version Number
3
DI Record Publish Date
January 18, 2018
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 | 472 |
2 | A medical device with a moderate to high risk that requires special controls. | 1994 |
U | Unclassified | 10 |