Duns Number:315304071
Device Description: WORKING INSERT FOR HYSTEROSCOPE 21FR with ramp, working channel 7Fr, compatible with oute WORKING INSERT FOR HYSTEROSCOPE 21FR with ramp, working channel 7Fr, compatible with outer sheath 8988031 for diagnostic hysteroscopy, and telescopes Ø 4mm, with Luer connection, bayonet-cap, reusable
Catalog Number
8988.241
Brand Name
NA
Version/Model Number
8988241
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
HIH
Product Code Name
HYSTEROSCOPE (AND ACCESSORIES)
Public Device Record Key
c41f4c2d-41ee-4df6-a08b-f403a0118fb6
Public Version Date
April 28, 2021
Public Version Number
7
DI Record Publish Date
September 23, 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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |