Duns Number:355804758
Device Description: Maxi Sky 2, Infection Control, 2F IC ECS - Ceiling Lift - Safe working load of 600 lb / 2 Maxi Sky 2, Infection Control, 2F IC ECS - Ceiling Lift - Safe working load of 600 lb / 272 kg.
Catalog Number
-
Brand Name
Maxi Sky 2
Version/Model Number
MS005
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FSA
Product Code Name
Lift, Patient, Non-Ac-Powered
Public Device Record Key
e3af8105-e9e8-42c8-97b8-c47c9c54b1e9
Public Version Date
August 08, 2022
Public Version Number
1
DI Record Publish Date
July 30, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 420 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 840 |