Duns Number:073814568
Device Description: Replacement foam 3 piece O.R. table pad set designed to fit an Amsco/Steris 4085 or 5085 O Replacement foam 3 piece O.R. table pad set designed to fit an Amsco/Steris 4085 or 5085 Operating Room table. The UltraCare Series is a dense supportive foam, a cradling visco foam top layer with a 4 way stretch covering.
Catalog Number
CMAX-SG
Brand Name
NA
Version/Model Number
CMAX-SG
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
2bb00fde-4eb7-4d9c-b3d9-c954c04b1d24
Public Version Date
July 15, 2022
Public Version Number
1
DI Record Publish Date
July 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 | 264 |