Duns Number:139534114
Catalog Number
-
Brand Name
TRIDENT HD SPECIMEN RADIOGRAPHY
Version/Model Number
TRI-00002
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K182727
Product Code
MWP
Product Code Name
Cabinet, x-ray system
Public Device Record Key
cf71cbb7-ce56-43e3-aa72-58d11def2e32
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
March 04, 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 | 130 |
2 | A medical device with a moderate to high risk that requires special controls. | 311 |
3 | A medical device with high risk that requires premarket approval | 96 |