Duns Number:657528899
Device Description: The ETO Sterilized Curette is used to obtain a sample of differentiated endometrial tissue The ETO Sterilized Curette is used to obtain a sample of differentiated endometrial tissue. The Curette is a 3mm (O.D.) endometrial suction curette with a Randall-like cutting edge at its distal end and packaged with a twist-and-lock syringe. The syringe provides the vacuum or suction during the procedure. The Curette is sterile unless the package is opened or damaged. It is designed for single patient use only.
Catalog Number
-
Brand Name
NA
Version/Model Number
RD003-W
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K092982,K092982
Product Code
HHK
Product Code Name
Curette, Suction, Endometrial (And Accessories)
Public Device Record Key
e25f16c4-4124-4436-9e3a-afae5f35afb4
Public Version Date
June 25, 2020
Public Version Number
4
DI Record Publish Date
August 15, 2016
Package DI Number
04715309129395
Quantity per Package
10
Contains DI Package
04715309129449
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 |