Duns Number:064730456
Device Description: A flexible, sterile cannula with a single large "scoop cut" type opening with no sharp edg A flexible, sterile cannula with a single large "scoop cut" type opening 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 that are also color-coded. This is single-use device, sealed into packaging and sterilized.
Catalog Number
-
Brand Name
WomanCare Global Flexible Karman Cannula, 10mm
Version/Model Number
FC10
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
b51ddef9-d540-448c-abb3-145744b88145
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 |