Denudation Pipettes
Denudation Pipettes remove cumulus material from oocytes before IVF or intracytoplasmic sperm injection. They also handle gametes, embryos and already biopsied cells during assisted…
Denudation Pipettes remove cumulus material from oocytes before IVF or intracytoplasmic sperm injection. They also handle gametes, embryos and already biopsied cells during assisted reproduction, but are not intended to perform the biopsy itself.
The pipettes are polycarbonate capillary tubes with a tapered distal tip and a 0.9 mm proximal outer diameter for fitting into an actuating device. Each is approximately 90 mm long.
Tip Sizes and Supply
Distal inner diameters range from 80 to 290 micrometers, providing size options for different handling tasks. Pipettes are radiation sterilized in pouches of five or ten and are disposable for a single use.
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Huada Biotechnology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
| Guangzhou Pinzhi Medical Device Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 5 |
Record
| Listed by | Guangzhou Pinzhi Medical Device Co., Ltd., China |
|---|---|
| FDA product code | MQH |
| Device type | Microtools, Assisted Reproduction (Pipettes) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6130 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K250838 |
| Record published | 2025-12-15 |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| S-P-PD150/10 | 10 | In distribution | |
| S-P-PD160/10 | 10 | In distribution | |
| S-P-PD130/10 | 10 | In distribution | |
| S-P-PD170/10 | 10 | In distribution | |
| S-P-PD290/10 | 10 | In distribution | |
| S-P-PD210/10 | 10 | In distribution | |
| S-P-PD140/10 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Wallace | ICU Medical, Inc | 452 |
| Microtools, Assisted Reproduction (Pipettes) | Origio, Inc. | 264 |
| RI Pipettes | Research Instruments Ltd | 201 |
| Icsi Pipette | Vitrolife Inc. | 75 |
| Biopsy Pipette | Vitrolife Inc. | 38 |
| EZ-Tip | Coopersurgical, Inc. | 29 |
| EZ-Tip | Research Instruments Ltd | 29 |
| Stripper | Origio, Inc. | 27 |
| Holding Pipette | Vitrolife Inc. | 25 |
| Cook | Cook Vandergrift Inc. | 15 |
| Hatching Pipette | Vitrolife Inc. | 15 |
| Cook Flexipet | Cook Vandergrift Inc. | 12 |
Showing 12 of 38. All products under Microtools, Assisted Reproduction (Pipettes)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250838 | 2025-07-03 |
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.