Duns Number:102726734
Device Description: 500 ml canister (with Gel) for VAC ATS Therapy Systems
Catalog Number
-
Brand Name
V.A.C. ATS™
Version/Model Number
M6275063/5 M6275063/10
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 04, 2018
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
-
Product Code
OMP
Product Code Name
Negative Pressure Wound Therapy Powered Suction Pump
Public Device Record Key
7079219f-feed-444e-a1b0-4c9c735c32e8
Public Version Date
September 09, 2020
Public Version Number
4
DI Record Publish Date
September 05, 2016
Package DI Number
00878237000854
Quantity per Package
10
Contains DI Package
00878237001677
Package Discontinue Date
June 04, 2018
Package Status
Not in Commercial Distribution
Package Type
10 Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 63 |