Duns Number:037304144
Device Description: Fhc Stretcher Pad 26” X 76” X 4” Poly Foam With Two Angled Corners And Two Rounded Corners Fhc Stretcher Pad 26” X 76” X 4” Poly Foam With Two Angled Corners And Two Rounded Corners With Dura-Comfort 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
BB26X76X4
Brand Name
FHC Stretcher Pad 26 X 76 X 4
Version/Model Number
BB26X76X4
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
3ed8b5ef-0577-455e-a962-f1ed46d92e1b
Public Version Date
September 30, 2020
Public Version Number
1
DI Record Publish Date
September 22, 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 |