Duns Number:054326178
Device Description: Sage Multi-Position MATS Mobile Air Transfer System
Catalog Number
3232
Brand Name
Sage Multi-Position MATS
Version/Model Number
3232
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CCX
Product Code Name
SUPPORT, PATIENT POSITION
Public Device Record Key
fc335083-d3c7-438b-b5a1-ef0f7567e144
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
October 15, 2021
Package DI Number
50618029760864
Quantity per Package
5
Contains DI Package
00618029760869
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 | 64 |
2 | A medical device with a moderate to high risk that requires special controls. | 12 |