Duns Number:207372814
Device Description: Molded cushion with an open center that helps relieve pressure by distributing body weight Molded cushion with an open center that helps relieve pressure by distributing body weight evenly. Made of urethane foam fill with a removable, washable white cloth cover.
Catalog Number
-
Brand Name
AMG Medical Foam Invalid Ring
Version/Model Number
745-173
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"
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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
KIC
Product Code Name
Cushion, Flotation
Public Device Record Key
a8fb0af0-af6d-4997-b59c-e4c949e05a6f
Public Version Date
August 21, 2020
Public Version Number
2
DI Record Publish Date
September 14, 2018
Package DI Number
05756596064586
Quantity per Package
12
Contains DI Package
00775757451732
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |