Duns Number:216344051
Device Description: NPWT Foam Wound Dressings for use with RENASYS and PICO NPWT Systems. 10cmx13cm
Catalog Number
66801021
Brand Name
Foam 10x12.5cm Pack 1
Version/Model Number
66801021
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
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
K142979,K142979
Product Code
OMP
Product Code Name
Negative Pressure Wound Therapy Powered Suction Pump
Public Device Record Key
e4725718-1a3c-47f8-814d-5a9df00eaa06
Public Version Date
May 18, 2020
Public Version Number
2
DI Record Publish Date
October 15, 2019
Package DI Number
30040565125900
Quantity per Package
5
Contains DI Package
00040565125909
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 | 63 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 126 |
| U | Unclassified | 1 |