Follicle Aspiration Needle – Single Lumen
Catalogue number #4551 FAS XD-BCB2, listed by Gynetics Medical Products NV, Belgium, under Needle, Assisted Reproduction. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Gynetics Medical Products NV, Belgium |
|---|---|
| FDA product code | MQE |
| Device type | Needle, Assisted Reproduction |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6100 |
| Establishment | Manufacturer |
| 510(k) | K013497 |
| Record published | 2016-11-03 |
| Record revised | 2018-07-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 0 to 30 °C |
| Packaging | Pack of 50, pack of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| #4551 FAS XD-BCB2 | 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 |
|---|---|
| K013497 | 2001-11-09 |
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.