OPU Needle
Kitazato OPU Needles collect oocytes from ovarian follicles during ultrasound-guided transvaginal retrieval. They are sterile, single-use aspiration devices connected to a collection tube…
Kitazato OPU Needles collect oocytes from ovarian follicles during ultrasound-guided transvaginal retrieval. They are sterile, single-use aspiration devices connected to a collection tube and vacuum pump, providing a pathway for removing follicular contents during assisted reproduction procedures.
Each needle assembly combines a stainless steel needle, a plastic hub, connection tubing and a silicone stopper. The product family includes straight needles and designs with one or two reductions in diameter near the tip. The selected needle configuration determines the shaft and tip dimensions.
Lumen and Sterilization
The needles use a single lumen for aspiration and are sterilized with ethylene oxide.
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Shenzhen VitaVitro Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Gimbo Medical Technology Shenzhen Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
Record
| Listed by | Kitazato Corporation, Japan |
|---|---|
| FDA product code | MQE |
| Device type | Needle, Assisted Reproduction |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6100 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K162881 |
| Record published | 2024-05-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature 2 to 8 °C |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OPU Needle | In distribution | |
| OPU Needle | In distribution | |
| OPU Needle | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cook | William A. Cook Australia PTY, Ltd. | 71 |
| Follicle Aspiration Set Single Lumen | Vitrolife Sweden AB | 40 |
| Follicle Aspiration Set, Double Lumen | Vitrolife Sweden AB | 28 |
| Wallace | ICU Medical, Inc | 20 |
| Kitazato OPU Needle with Connection Tube, Type2-v17 | Kitazato Corporation | 18 |
| Labotect | Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung | 16 |
| Kitazato OPU Needle | Kitazato Corporation | 12 |
| Follicle Aspiration Set Reduced Single Lumen | Vitrolife Sweden AB | 11 |
| Follicle Aspiration Set Single Lumen, Luer | Vitrolife Sweden AB | 9 |
| Needle Guide | Civco Medical Instruments Co., Inc. | 8 |
| 17G Wallace Dual Lumen Oocyte Recovery Set | Coopersurgical, Inc. | 3 |
| ACE-M | Allwin Medical Devices, Inc. | 3 |
Showing 12 of 65. All products under Needle, Assisted Reproduction
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162881 | 2017-07-11 |
| K112462 | 2012-11-26 |
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.