Duns Number:037304144
Device Description: Amsco 2080 Deluxe Operating Room Table Pad 2 Thick (Set Of 3). 2860 High-Density Polyuret Amsco 2080 Deluxe Operating Room Table Pad 2 Thick (Set Of 3). 2860 High-Density Polyurethane Foam With A Soft Stretchable Urethane-Coated Conductive Top Cover And A Conductive Vinyl Sheeting Bottom Cover. This Pad Is Recommended As An Upgrade Over The Standard Pad For Short To Medium Length Procedures.
Catalog Number
BB2080D
Brand Name
Pad Amsco Deluxe 2080 2 Thick (Set Of 3)
Version/Model Number
BB2080D
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
b5efed60-b665-40dd-b0f8-f94db27e0c12
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 |