Duns Number:216344051
Device Description: RENASYS TOUCH 300ml Canister with Solidifier
Catalog Number
66801273
Brand Name
RENASYS TOUCH
Version/Model Number
66801273
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
K153209,K153209
Product Code
OMP
Product Code Name
Negative Pressure Wound Therapy Powered Suction Pump
Public Device Record Key
d458c2ba-f59a-4218-bbd3-836e44cca3eb
Public Version Date
November 23, 2021
Public Version Number
4
DI Record Publish Date
November 02, 2016
Package DI Number
30040565126525
Quantity per Package
5
Contains DI Package
00040565126524
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 |