Duns Number:153608369
Device Description: DRESSING CHANGE KIT
Catalog Number
MSSQ-020624
Brand Name
MedStream
Version/Model Number
MSSQ-020624
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OXQ
Product Code Name
Dressing Change Tray
Public Device Record Key
80704cf9-1611-4f0b-ae4f-45ac9323ca82
Public Version Date
October 06, 2020
Public Version Number
4
DI Record Publish Date
July 17, 2017
Package DI Number
10842472106180
Quantity per Package
5
Contains DI Package
00842472106183
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 202 |
2 | A medical device with a moderate to high risk that requires special controls. | 86 |