Duns Number:324868165
Device Description: Continuous flow Hysteroscopy sheathHigh Flow, ø5,5mm, 5Ch working channelwith stopcock, 2 Continuous flow Hysteroscopy sheathHigh Flow, ø5,5mm, 5Ch working channelwith stopcock, 2 stopcocks blue,working length 212mm, to use with scope ø 2,9mm 30°, length 303mm
Catalog Number
-
Brand Name
Hermann Medizintechnik GmbH
Version/Model Number
H51-270-000SH
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
-
Product Code
NWW
Product Code Name
Hysteroscope accessories
Public Device Record Key
64a1c545-df62-4360-aeb9-2c6f549a7ea1
Public Version Date
September 29, 2021
Public Version Number
1
DI Record Publish Date
September 21, 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 | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 607 |