Duns Number:961027315
Device Description: NPWT IM Dressing Kit OD, 10x20cm
Catalog Number
49-4800
Brand Name
Kendall
Version/Model Number
49-4800
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 30, 2022
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
cb930b78-db0d-4c31-b889-6fa5bca6c44f
Public Version Date
June 30, 2022
Public Version Number
4
DI Record Publish Date
August 18, 2020
Package DI Number
50885380165151
Quantity per Package
10
Contains DI Package
10885380165153
Package Discontinue Date
June 29, 2022
Package Status
Not 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 |