Duns Number:543045577
Device Description: Medical Trolley are intended to mount and position medical electrical equipment (hereafter Medical Trolley are intended to mount and position medical electrical equipment (hereafter referred to as ME equipment) and accessories to those and are used in operating theaters as well as treatment rooms as auxiliary devices for doctors and medical staff.
Catalog Number
-
Brand Name
CORITON
Version/Model Number
E.W.TG.TR900C-12-02
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
Yes
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
BZN
Product Code Name
Cart, Emergency, Cardiopulmonary (Excluding Equipment)
Public Device Record Key
c4f0e3b5-57ec-4df1-b0dc-97e357c40667
Public Version Date
January 24, 2022
Public Version Number
1
DI Record Publish Date
January 15, 2022
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 | 1 |