Duns Number:867673159
Device Description: Bath SafetyBenches/Stools Product Description: AQUA. BAR. BATH BENCH W/BACK, WHITE,1EA
Catalog Number
-
Brand Name
Aquasence
Version/Model Number
770-532
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 26, 2019
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
ILS
Product Code Name
ADAPTOR, HYGIENE
Public Device Record Key
2094d95d-44f9-4dbf-bdb5-48568bff63b8
Public Version Date
June 02, 2020
Public Version Number
2
DI Record Publish Date
June 25, 2019
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 | 3783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 832 |