Duns Number:130789944
Device Description: Nonsterile Equipment Large Cover for the Movement Footswitch 26” x 26”
Catalog Number
FTSXCVRLG
Brand Name
Dornier MedTech
Version/Model Number
Equipment Cover (Movement Footswitch)
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"
Yes
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
IZI
Product Code Name
System, X-Ray, Angiographic
Public Device Record Key
b0f9084a-82c9-455c-995a-c7213c54812e
Public Version Date
March 25, 2020
Public Version Number
1
DI Record Publish Date
March 17, 2020
Package DI Number
10810116023025
Quantity per Package
100
Contains DI Package
00810116023028
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |