Duns Number:961027315
Device Description: 6x8 incision management dressing kit
Catalog Number
49-6800SL
Brand Name
Kendall
Version/Model Number
49-6800SL
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"
Yes
For Single-Use
Yes
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
OMP
Product Code Name
negative pressure wound therapy Powered suction pump
Public Device Record Key
d83516fc-103d-4faa-a0dc-040d8ca37d27
Public Version Date
March 18, 2022
Public Version Number
1
DI Record Publish Date
March 10, 2022
Package DI Number
50885380165229
Quantity per Package
10
Contains DI Package
10885380165221
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |