Duns Number:216344051
Device Description: PICO Single Use Negative Pressure Wound Therapy System 10cm x 20cm 4in. x 8in.
Catalog Number
66800951
Brand Name
PICO
Version/Model Number
66800951
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
-
Product Code
OMP
Product Code Name
Negative Pressure Wound Therapy Powered Suction Pump
Public Device Record Key
39a6c37a-13bd-4861-ad7b-deca7e1f95a4
Public Version Date
November 23, 2021
Public Version Number
4
DI Record Publish Date
September 20, 2016
Package DI Number
05000223477080
Quantity per Package
3
Contains DI Package
05000223477073
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 |