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 plaid cloth cover.
Catalog Number
745-166
Brand Name
AMG Medical Foam Invalid Ring
Version/Model Number
745-166
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 19, 2021
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)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
KIC
Product Code Name
Cushion, Flotation
Public Device Record Key
d1e4e6b5-54d5-4696-906f-81c762924c90
Public Version Date
October 20, 2021
Public Version Number
3
DI Record Publish Date
September 07, 2018
Package DI Number
05756596061448
Quantity per Package
12
Contains DI Package
01775757451731
Package Discontinue Date
October 19, 2021
Package Status
Not 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 |