Duns Number:964322929
Device Description: Schure Socket
Catalog Number
800-0006
Brand Name
SchureMed
Version/Model Number
800-0006
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 02, 2021
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
FWZ
Product Code Name
Operating Room Accessories Table Tray
Public Device Record Key
9d5b5917-c04b-411e-a4c1-02eefb61b733
Public Version Date
September 03, 2021
Public Version Number
2
DI Record Publish Date
February 15, 2019
Package DI Number
01810014600009
Quantity per Package
1
Contains DI Package
00810014600000
Package Discontinue Date
September 02, 2021
Package Status
Not 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 | 1128 |