Duns Number:658863238
Device Description: Relief Cushion Cover 16 x 20" TDX H&R-1p
Catalog Number
-
Brand Name
NA
Version/Model Number
S2204-A060
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
-
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
010d065c-5d2f-4c12-8a02-b4f32d9ab7c6
Public Version Date
March 30, 2020
Public Version Number
3
DI Record Publish Date
March 22, 2017
Package DI Number
04713616093477
Quantity per Package
10
Contains DI Package
04713616092715
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 144 |