Duns Number:080935429
Device Description: Express Tear-Away Sleeves,Thigh Length, Small
Catalog Number
73041
Brand Name
Kendall SCD
Version/Model Number
73041
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
-
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
fd059140-ff29-495b-9212-a565f15376e8
Public Version Date
January 05, 2021
Public Version Number
8
DI Record Publish Date
September 24, 2016
Package DI Number
40884521052179
Quantity per Package
5
Contains DI Package
30884521052172
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 |