Duns Number:037304144
Device Description: Fhc Standard Stretcher Pad 25 X 75 X 4 Poly Foam Dura-Comfort Cover W/ 2 Angled & 2 Rounde Fhc Standard Stretcher Pad 25 X 75 X 4 Poly Foam Dura-Comfort Cover W/ 2 Angled & 2 Rounded Corners Material With 2 Wide Loop Velcro Sewn To Bottom Of The Pads And Mating Adhesive Hook Velcro Supplied Just Peel The Adhesive And Place The Pad Onto Stretcher
Catalog Number
BB25X75X4
Brand Name
Stretcher Pad Standard 25 X 75 X 4 Dura-Comfort Cover
Version/Model Number
BB25X75X4
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
f30c7023-039c-477d-9cfb-ce5d2b60089d
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 |