The MatrixBrush Endometrial Sampler is a sterile, single-use endometrial tissue sampling device. The MatrixBrush shaft is comprised of a spirally twisted stainless steel core covered by…
The MatrixBrush Endometrial Sampler is a sterile, single-use endometrial tissue sampling device. The MatrixBrush shaft is comprised of a spirally twisted stainless steel core covered by plastic with marked gradations. A nylon brush head at the distal end of the device collects a tissue sample and an atraumnatic plastic bulb located on the extreme distal end protects the patient from penetration. A moveable plastic sheath overlies the brush head and device shaft.
Who Else Makes It
Concentrated in Zhejiang (1), Jiangsu (1).
Record
Regulatory record for MatrixBrush Endometrial Sampler | Listed by | Post OAK Innovations, Inc., United States |
| FDA product code | HFE |
| Device type | Brush, Endometrial |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1100 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2020-04-23 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
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.