Duns Number:252468293
Device Description: A 18" Grab Bar that is fixed to the wall and is of differing bar shaped designs that is in A 18" Grab Bar that is fixed to the wall and is of differing bar shaped designs that is intended to provide a person with a disability a supportive hand-hold whilst standing and moving. May be mounted in any room of the home.
Catalog Number
00543
Brand Name
Easy Mount™ 9 Hole Flange w/Cover (KNURLED STEEL 1 PK)
Version/Model Number
G125SK18F9
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
IKX
Product Code Name
Aid, Transfer
Public Device Record Key
545d7e6b-52ac-47ba-967a-15ff6a1a8057
Public Version Date
September 02, 2021
Public Version Number
1
DI Record Publish Date
August 25, 2021
Package DI Number
10689281005439
Quantity per Package
10
Contains DI Package
00689281005432
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 298 |