Duns Number:080935429
Device Description: Sequential Compression Comfort Sleeves,Thigh Length, X-Small
Catalog Number
74010
Brand Name
Kendall SCD
Version/Model Number
74010
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
236c74b3-d198-4d0f-8413-7355a1939eee
Public Version Date
June 17, 2019
Public Version Number
7
DI Record Publish Date
September 24, 2016
Package DI Number
20884521130811
Quantity per Package
5
Contains DI Package
10884521130814
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 |