Duns Number:964322929
Device Description: E-Z Lift Beach Chair with Connection Holder (EU)
Catalog Number
-
Brand Name
SchureMed
Version/Model Number
800-0142-S-EU
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
FSE
Product Code Name
Table, Operating-Room, Manual
Public Device Record Key
96e8962d-72a8-4a4c-89bb-cca3c6aa49f5
Public Version Date
September 20, 2021
Public Version Number
1
DI Record Publish Date
September 10, 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 | 1128 |