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…
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.
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Curette, Suction, Endometrial (And Accessories) | Listed by | Panpac Medical Corporation, Taiwan |
| FDA product code | HHK |
| Device type | Curette, Suction, Endometrial (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1175 |
| Record published | 2016-08-15 |
| Record revised | 2022-11-07 (version 5) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 25, box of 10 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.