Duns Number:002144145
Device Description: Electrode - Ball Tip. 5Fr (1.6mm nom.) x 360mm.
Catalog Number
00466
Brand Name
GYNECARE VERSAPOINT
Version/Model Number
00466
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 21, 2021
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
-
Product Code
HIH
Product Code Name
HYSTEROSCOPE (AND ACCESSORIES)
Public Device Record Key
b1626b0f-dfa7-4a86-8cf0-7d2bdec39a31
Public Version Date
December 22, 2021
Public Version Number
5
DI Record Publish Date
September 16, 2016
Package DI Number
20705031000770
Quantity per Package
5
Contains DI Package
10705031000773
Package Discontinue Date
December 21, 2021
Package Status
Not in Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1128 |
| 3 | A medical device with high risk that requires premarket approval | 4 |
| U | Unclassified | 1 |