Duns Number:315304071
Device Description: INTRAUTERINE PROBE Ø 32MM WL 32MM by Cohen, for introduction of fluid for hysterosalpingo INTRAUTERINE PROBE Ø 32MM WL 32MM by Cohen, for introduction of fluid for hysterosalpingography, TL 330mm, with Luer connection, reusable
Catalog Number
8378.00
Brand Name
NA
Version/Model Number
837800
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
HHI
Product Code Name
System, abortion, vacuum
Public Device Record Key
08741ea4-0768-474e-a13c-90d7db144e3b
Public Version Date
April 19, 2021
Public Version Number
5
DI Record Publish Date
September 26, 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 |