Duns Number:245253575
Device Description: Revolving Stool - as above but adj. 25 in to 32 in
Catalog Number
OR-36230
Brand Name
Imperial Stainless Steel Revolving Stool
Version/Model Number
OR-36230
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"
Yes
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
FZM
Product Code Name
Stool, Operating-Room
Public Device Record Key
886830a7-fef5-41af-a8c3-a425a83b2039
Public Version Date
January 21, 2021
Public Version Number
1
DI Record Publish Date
January 13, 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 | 77 |
2 | A medical device with a moderate to high risk that requires special controls. | 6 |