Duns Number:037304144
Device Description: 3100 Operating Room Table Pad 2 Thick (Set Of 2). 2860 High Density Foam Non-Latex With ' 3100 Operating Room Table Pad 2 Thick (Set Of 2). 2860 High Density Foam Non-Latex With 'Lectrolite Conductive Covering. With Velcro Kit
Catalog Number
BB3100
Brand Name
Pad Skytron 3100 2 Thick (2/St)
Version/Model Number
BB3100
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
8c6489c2-c98f-439b-87d6-e38ccefa00a9
Public Version Date
September 18, 2020
Public Version Number
1
DI Record Publish Date
September 10, 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 |