Duns Number:058614483
Device Description: Marker Delivery Kit
Catalog Number
-
Brand Name
superDimension
Version/Model Number
SDMDK1000
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JAK
Product Code Name
System, x-ray, tomography, computed
Public Device Record Key
29a3f140-c090-429a-b757-bf3baef88759
Public Version Date
April 08, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20884521200521
Quantity per Package
5
Contains DI Package
10884521200524
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |