Duns Number:080826327
Device Description: The LUMINELLE DTx Hysteroscopy System with the LUMINELLE Dx 360° Rotatable Disposable Shea The LUMINELLE DTx Hysteroscopy System with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic).
Catalog Number
20070
Brand Name
LUMINELLE Dx 360o Rotatable Disposable Sheath (Diagnostic)
Version/Model Number
LUMDx-360
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"
Yes
For Single-Use
Yes
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
K192278,K192278
Product Code
FAJ
Product Code Name
Cystoscope And Accessories, Flexible/Rigid
Public Device Record Key
0dc9e3e0-441f-4175-9dfa-a41f89cccfc9
Public Version Date
November 15, 2019
Public Version Number
1
DI Record Publish Date
November 07, 2019
Package DI Number
10853277008067
Quantity per Package
5
Contains DI Package
00853277008060
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pouch
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |