Duns Number:305656662
Device Description: SELECT TL4 toilet bracket, for floor outlet, prepared for shower toilet seat, 120V, white SELECT TL4 toilet bracket, for floor outlet, prepared for shower toilet seat, 120V, white single molded cover. Manually height adjustable with crank handle
Catalog Number
R9034000
Brand Name
SELECT TL4
Version/Model Number
R9034
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 16, 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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IKX
Product Code Name
Aid, Transfer
Public Device Record Key
11513e13-1df3-4bc3-91e7-ccf7951bbf0d
Public Version Date
February 16, 2021
Public Version Number
2
DI Record Publish Date
August 06, 2020
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 | 319 |