Duns Number:305656662
Device Description: PLUS support arm, 850 mm, dark blue. Height and sideways adjustable, right hand operated, PLUS support arm, 850 mm, dark blue. Height and sideways adjustable, right hand operated, for retro-fitting
Catalog Number
R391485108
Brand Name
PLUS
Version/Model Number
R391485
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)
Yes
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
a8337a0c-e037-43d2-97f7-57643866d4fd
Public Version Date
June 16, 2020
Public Version Number
1
DI Record Publish Date
June 08, 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 |