Duns Number:242049828
Catalog Number
412004
Brand Name
Laguna Mist Flex with Armrest 230V
Version/Model Number
412004
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 10, 2019
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
LGX
Product Code Name
Table, Examination, Medical, Powered
Public Device Record Key
207625e4-1eff-4dbf-b27f-51bb37243b94
Public Version Date
July 11, 2019
Public Version Number
4
DI Record Publish Date
June 16, 2017
Package DI Number
00667259000443
Quantity per Package
1
Contains DI Package
00667259000030
Package Discontinue Date
July 10, 2019
Package Status
Not in Commercial Distribution
Package Type
skid
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 52 |
2 | A medical device with a moderate to high risk that requires special controls. | 3 |