Duns Number:080935429
Device Description: Express Sleeves, Knee Length, X-Large
Catalog Number
9790R
Brand Name
Kendall SCD
Version/Model Number
9790R
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
JOW
Product Code Name
SLEEVE, LIMB, COMPRESSIBLE
Public Device Record Key
25d7231a-0407-43e1-8ef1-ac16436e7a85
Public Version Date
November 16, 2020
Public Version Number
7
DI Record Publish Date
July 06, 2017
Package DI Number
20884521213637
Quantity per Package
5
Contains DI Package
10884521213630
Package Discontinue Date
-
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 |