Duns Number:824793335
Catalog Number
-
Brand Name
MAXI 4000 EXAM CHAIR, WITH MOTORIZED LIFT/RECLINE TO FLAT, ONE MEMORY, ARTICULAT
Version/Model Number
S 4001000
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRK
Product Code Name
Chair, Examination And Treatment
Public Device Record Key
d659b329-807f-4832-a094-b95f6c0e9d11
Public Version Date
September 28, 2021
Public Version Number
1
DI Record Publish Date
September 20, 2021
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 | 396 |