Duns Number:705464292
Device Description: Disposable hysteroscope with a working channel suitable for 5Fr tools to cut and remove ut Disposable hysteroscope with a working channel suitable for 5Fr tools to cut and remove uterine lesions and take a biopsy. The outer diameter of the scope is 4.5 mm.
Catalog Number
-
Brand Name
HTx Disposable Hysteroscope
Version/Model Number
HTx40
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
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
K211227,K211227
Product Code
HIH
Product Code Name
Hysteroscope (And Accessories)
Public Device Record Key
9af93c53-0df9-44d9-85ff-fe3dc0aa4c27
Public Version Date
April 11, 2022
Public Version Number
1
DI Record Publish Date
April 01, 2022
Package DI Number
26974880990035
Quantity per Package
6
Contains DI Package
06974880990031
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |