Duns Number:080570262
Device Description: Aveta Opal Reusable Cable for use with Aveta Opal Disposable Hysteroscope, 4.6mm and Aveta Aveta Opal Reusable Cable for use with Aveta Opal Disposable Hysteroscope, 4.6mm and Aveta System
Catalog Number
220-2011
Brand Name
Aveta Opal Reusable Cable
Version/Model Number
220-2011
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K190372
Product Code
HIG
Product Code Name
Insufflator, Hysteroscopic
Public Device Record Key
af5f84e8-235c-4e3b-a1ee-a2adda9f1fc3
Public Version Date
July 01, 2021
Public Version Number
1
DI Record Publish Date
June 23, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |