Duns Number:073260622
Catalog Number
1506-18
Brand Name
CT/MR M.A.C. Interstitial GYN Template,18G Bebig
Version/Model Number
1506-18
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
-
Product Code
JAQ
Product Code Name
System, Applicator, Radionuclide, Remote-Controlled
Public Device Record Key
629478f5-e46e-42d8-b897-af2a96ba5434
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 26, 2016
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 | 13 |
2 | A medical device with a moderate to high risk that requires special controls. | 659 |