Duns Number:080935429
Device Description: Buttonhole Belt,Pink and Blue Striped
Catalog Number
56101
Brand Name
Kendall
Version/Model Number
56101
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
July 01, 2023
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FSD
Product Code Name
BINDER, ABDOMINAL
Public Device Record Key
0c0307f3-5e69-4cfa-acc8-facc06587f4a
Public Version Date
November 24, 2020
Public Version Number
4
DI Record Publish Date
June 30, 2018
Package DI Number
10884527005314
Quantity per Package
50
Contains DI Package
20884527005311
Package Discontinue Date
July 01, 2023
Package Status
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 |