Duns Number:631770658
Device Description: Ped Medium 2 Positioners Kit with Cover 16x24 and 7x10
Catalog Number
-
Brand Name
Mölnlycke®Z-Flo™ Fluidized Positioner
Version/Model Number
1400304
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMP
Product Code Name
Protector, skin pressure
Public Device Record Key
d06a332c-43d0-404b-ad39-46cf83399b31
Public Version Date
October 31, 2022
Public Version Number
1
DI Record Publish Date
October 21, 2022
Package DI Number
07323190270101
Quantity per Package
6
Contains DI Package
07323190276325
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 | 212 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |
| U | Unclassified | 18 |