Duns Number:004253936
Device Description: Ultra Care OR Table Pad, 3pc. 2", 6500UC
Catalog Number
91794
Brand Name
C-MATT
Version/Model Number
91794
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
LWG
Product Code Name
SURGICAL TABLE CUSHION
Public Device Record Key
88ec9805-e8a7-47b5-b33a-4d3d847dd757
Public Version Date
November 19, 2020
Public Version Number
2
DI Record Publish Date
July 10, 2019
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 | 849 |
2 | A medical device with a moderate to high risk that requires special controls. | 1 |