Duns Number:608736880
Catalog Number
-
Brand Name
ADVANCED TROLLEY
Version/Model Number
MT-2000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
April 30, 2028
Issuing Agency
In HIBCC
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
KMN
Product Code Name
Chair And Table, Medical
Public Device Record Key
3ae3324d-9be4-4cd9-8380-f325c080c397
Public Version Date
June 04, 2020
Public Version Number
1
DI Record Publish Date
May 27, 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 | 18 |
2 | A medical device with a moderate to high risk that requires special controls. | 32 |