Duns Number:027680821
Device Description: Intended to act as an ergonomic product that reduces fatigue of nurses and surgeons experi Intended to act as an ergonomic product that reduces fatigue of nurses and surgeons experienced from long hours of standing in one location.
Catalog Number
-
Brand Name
ErgoSupport Step Stool, non-sterile
Version/Model Number
ST-001
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)
-
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
10ab160b-d70c-4a44-8892-44c393950f09
Public Version Date
March 05, 2021
Public Version Number
1
DI Record Publish Date
February 25, 2021
Package DI Number
00840113207404
Quantity per Package
4
Contains DI Package
00840113207411
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 952 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 494 |