Duns Number:808875397
Device Description: kVue Encompass SRS Insert with E0 headrest & hand grip array
Catalog Number
RT-4600KV-01
Brand Name
Encompass™
Version/Model Number
RT-4600KV-01
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K152321
Product Code
IYE
Product Code Name
Accelerator, linear, medical
Public Device Record Key
2be32e21-1869-4824-8a89-1927b5276b84
Public Version Date
March 11, 2019
Public Version Number
4
DI Record Publish Date
September 14, 2016
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 | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 998 |