Duns Number:009120817
Device Description: For Titanium Fletcher-style Applicator Set (CT & MR compatible, flexible geometry)
Catalog Number
GM11006680
Brand Name
Titanium intrauterine probe, 15 degrees angle, Titanium
Version/Model Number
GM11006680
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
K952913
Product Code
JAQ
Product Code Name
System, applicator, radionuclide, remote-controlled
Public Device Record Key
edd74b31-d446-4588-bd42-a62e80982911
Public Version Date
February 10, 2021
Public Version Number
1
DI Record Publish Date
February 02, 2021
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 253 |