Duns Number:016898496
Device Description: Bard Metal Sound Adult Male Length with Prostatic Curve, Stainless Steel 28 Fr.
Catalog Number
604928
Brand Name
Bard® Metal Sound, Adult Male Length With Prostatic Curve
Version/Model Number
604928
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
e91ec24f-7579-49c6-bbe6-908f027b71c4
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 |