Duns Number:316152610
Device Description: ALPHASCOPE II CYSTO/HYSTEROSCOPEØ 2.9 MM / 30° HMWORKING LENGTH 300 MM, AUTOCLAVABLE
Catalog Number
E.8297.43 I
Brand Name
Gimmi
Version/Model Number
E.8297.43 I
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
-
Product Code
HIH
Product Code Name
HYSTEROSCOPE (AND ACCESSORIES)
Public Device Record Key
318aa3bd-3b50-4863-ae0f-1469e4b98bb3
Public Version Date
March 30, 2022
Public Version Number
3
DI Record Publish Date
May 05, 2017
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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 925 |