Duns Number:080935429
Device Description: Ultrasound Gel Bottle
Catalog Number
4060
Brand Name
Kendall
Version/Model Number
4060
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 18, 2021
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
MUI
Product Code Name
Media,coupling,ultrasound
Public Device Record Key
10b69c83-34d0-4f73-86bf-0a49e1d62399
Public Version Date
June 10, 2022
Public Version Number
9
DI Record Publish Date
September 24, 2016
Package DI Number
20884527017284
Quantity per Package
12
Contains DI Package
30884527017281
Package Discontinue Date
February 18, 2021
Package Status
Not in Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 672 |
2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
U | Unclassified | 17 |