Duns Number:122240021
Device Description: Accessory to the 1230 3D SCANNER used to measure the Tissue Phantom Ratio
Catalog Number
1230000-4Z
Brand Name
3D TPR
Version/Model Number
1230680Z
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 02, 2019
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K101992
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
e63d3068-822d-4258-9ec4-d4634df257d0
Public Version Date
August 28, 2019
Public Version Number
2
DI Record Publish Date
April 23, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 26 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 112 |