Duns Number:808875397
Device Description: SRS Adapter for Portrait™ and S-Type Devices
Catalog Number
RT-4600-03
Brand Name
SRS Adapter
Version/Model Number
RT-4600-03
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
K182189
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
45af5d03-7f6d-44ba-8a72-2eb2c4336e92
Public Version Date
March 03, 2020
Public Version Number
3
DI Record Publish Date
October 09, 2018
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 |