Duns Number:064730456
Device Description: A flexible, sterile cannula with two "whistle cut" type openings with no sharp edges. Cann A flexible, sterile cannula with two "whistle cut" type openings with no sharp edges. Cannulae feature dots as indicators for measuring the depth of the uterus. Cannulae, regardless of size, have a number identifying the size of cannula. The cannulae are color-coded and use adapters with the same color-coding. This is a single-use device, sealed into packaging and sterilized.
Catalog Number
-
Brand Name
WomanCare Global Flexible Karman Cannula, 7mm
Version/Model Number
FC7
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
Yes
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
HGH
Product Code Name
Cannula, Suction, Uterine
Public Device Record Key
f6c77453-7578-4d35-a888-f9a8563896e8
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 17, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 34 |