Duns Number:657528899
Device Description: "Measure uterine depth. Dilate the cervix if necessary. Introduce INTRACURETTE through the "Measure uterine depth. Dilate the cervix if necessary. Introduce INTRACURETTE through the cervical canal into the uterus up to the fundus. Connect the curette to the suction system. Operate by rotating the curette 360∘ to aspirate throughout the uterus cavity accurately.Repeat the operation two or three times. Withdraw INTRACURETTE from the uterus while continuing the rotating movement. "
Catalog Number
-
Brand Name
NA
Version/Model Number
CuRs11
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)
Yes
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
K161106,K161106
Product Code
HGH
Product Code Name
Cannula, Suction, Uterine
Public Device Record Key
39d26ba1-187b-4852-b14e-a44e0104b8c0
Public Version Date
June 25, 2020
Public Version Number
4
DI Record Publish Date
May 10, 2017
Package DI Number
04715309125328
Quantity per Package
10
Contains DI Package
04715309124802
Package Discontinue Date
-
Package Status
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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 676 |
| U | Unclassified | 1 |