Duns Number:037304144
Device Description: Steris C-Max, 4085 & 5085 Operating Room Table Pad 2 Thick (Set Of 3). 2860 High-Density Steris C-Max, 4085 & 5085 Operating Room Table Pad 2 Thick (Set Of 3). 2860 High-Density Polyurethane Foam Non-Latex With Conductive Vinyl Sheeting Top And Bottom Cover With Velcro Kit. This Pad Is Recommended For Shorter Procedures.
Catalog Number
BBCMAX
Brand Name
Pad Steris C-Max,4085 & 5085 2 Thick (Set Of 3)
Version/Model Number
BBCMAX
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
8d3a0766-6f1d-4dcd-9fa8-30ee2e582a7b
Public Version Date
September 24, 2020
Public Version Number
1
DI Record Publish Date
September 16, 2020
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 | 287 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |