Duns Number:958758146
Device Description: Convoluted (Eggcrate) Bed Overlay Pad (72" x 32" x 4")
Catalog Number
ECP72324
Brand Name
Convoluted (Eggcrate) Bed Overlay Pad
Version/Model Number
ECP72324
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
Yes
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
ILZ
Product Code Name
Accessories, Traction
Public Device Record Key
bdf0151e-6312-4d4a-a88c-10e97d9edf8f
Public Version Date
August 03, 2021
Public Version Number
1
DI Record Publish Date
July 26, 2021
Package DI Number
10810006684169
Quantity per Package
8
Contains DI Package
00810006684162
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Each
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 208 |