Duns Number:315494757
Device Description: XD 8000, ulrichINJECT CT motion composed of:
Catalog Number
XD 8000
Brand Name
UL_INJECT
Version/Model Number
XD 8000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171392,K192872,K210541
Product Code
IZQ
Product Code Name
Injector, contrast medium, automatic
Public Device Record Key
bb1918ab-848f-42f7-8765-bb4881b49850
Public Version Date
April 29, 2022
Public Version Number
3
DI Record Publish Date
March 12, 2019
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1439 |