Duns Number:051194887
Device Description: EP 310 No Heat, Massage Only - Seamless
Catalog Number
S1A4
Brand Name
n/a
Version/Model Number
S1A4
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
NRU
Product Code Name
Chair, Dental, Without Operative Unit
Public Device Record Key
bf9e3f2e-b796-46d4-ac65-f28b03023b35
Public Version Date
October 31, 2022
Public Version Number
2
DI Record Publish Date
September 07, 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 | 25 |