Needle Guide
Sterile endocavity needle guide for use with Siemens EC9-4 (on Sonoline Antares and S2000); Canon Medical Systems PVF-651VT, PVM-651VT, PVN-661VT, PVQ-641V, PVT-661VT transducers One-cell…
Sterile endocavity needle guide for use with Siemens EC9-4 (on Sonoline Antares and S2000); Canon Medical Systems PVF-651VT, PVM-651VT, PVN-661VT, PVQ-641V, PVT-661VT transducers One-cell MEA: =80% embryo developed to expand cytoblast at 96 hours USP Endotoxin (LAL) tested and passed with 20 EU or less per device.
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 | Civco Medical Instruments Co., Inc., United States |
|---|---|
| FDA product code | MQE |
| Device type | Needle, Assisted Reproduction |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6100 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K231783 |
| Record published | 2024-06-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep Away from Sunlight |
| Packaging | Pack of 24, pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 844-001 | In distribution | |
| 842-001 | In distribution | |
| 842-004 | In distribution | |
| 842-002 | In distribution | |
| 867-005 | In distribution | |
| 876-001 | In distribution | |
| 810-400 | In distribution | |
| 867-001 | 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 |
| 17G Wallace Dual Lumen Oocyte Recovery Set | Coopersurgical, Inc. | 3 |
| ACE-M | Allwin Medical Devices, Inc. | 3 |
| Vacuum Pump Tubing | Vitrolife Sweden AB | 3 |
Showing 12 of 65. All products under Needle, Assisted Reproduction
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.