Duns Number:216344051
Device Description: RENASYS-G Gauze Dressing Kit with Soft Port Small
Catalog Number
66020933
Brand Name
RENASYS G SMALL W/SOFT PORT
Version/Model Number
66020933
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K162129,K162129
Product Code
OMP
Product Code Name
Negative Pressure Wound Therapy Powered Suction Pump
Public Device Record Key
5a300970-c6f4-4999-9dfd-f8f9d460020e
Public Version Date
May 04, 2020
Public Version Number
1
DI Record Publish Date
April 24, 2020
Package DI Number
30040565127195
Quantity per Package
5
Contains DI Package
00040565127194
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 |