Duns Number:037304144
Device Description: Stretcher Pad 24 X 72 X 3 With Dura-Comfort Material. 2 Angled And 2 Rounded Corners With Stretcher Pad 24 X 72 X 3 With Dura-Comfort Material. 2 Angled And 2 Rounded Corners With Velcro Kit
Catalog Number
BB24X72X3
Brand Name
Stretcher Pad 24 X 72 X 3 W Dura-Comfort Cover
Version/Model Number
BB24X72X3
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
ddd0f521-407c-48ea-a1e9-7b79ede788a8
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 |