Sydney IVF
Sydney IVF, Blastocyst Cryopreservation KIT
4manufacturers in China registered for this device type
29catalogue numbers in this listing
10510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (3), Shandong (1).
| 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 |
| Shandong Wego Ruisheng Medical Device Co., Ltd. | Weihai | Shandong | Manufacturer | 2 |
Record
| Listed by | William A. Cook Australia PTY, Ltd., Australia |
|---|---|
| FDA product code | MQL |
| Device type | Media, Reproductive |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6180 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K152782 |
| Record published | 2016-12-15 |
| Record revised | 2023-11-02 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place |
| Distribution end date | 2023-10-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G46314 | In distribution | |
| G46295 | In distribution | |
| G46298 | In distribution | |
| G46307 | Withdrawn | |
| G46291 | Withdrawn | |
| G46313 | Withdrawn | |
| G46312 | Withdrawn | |
| G46310 | Withdrawn | |
| G46318 | Withdrawn | |
| G46300 | Withdrawn | |
| G46320 | Withdrawn | |
| G46303 | Withdrawn | |
| G46292 | Withdrawn | |
| G46293 | Withdrawn | |
| G46304 | Withdrawn | |
| G46309 | Withdrawn | |
| G46311 | Withdrawn | |
| G46294 | Withdrawn | |
| G46305 | Withdrawn | |
| G46308 | Withdrawn | |
| G46297 | Withdrawn | |
| G46301 | Withdrawn | |
| G46316 | Withdrawn | |
| G46315 | Withdrawn | |
| G46306 | Withdrawn | |
| G46299 | Withdrawn | |
| G46317 | Withdrawn | |
| G46296 | Withdrawn | |
| G46302 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LifeGlobal® Media | LifeGlobal Group, LLC | 93 |
| LifeGlobal® Media | Coopersurgical, Inc. | 27 |
| VitaVitro | Shenzhen VitaVitro Biotech Co., Ltd. | 22 |
| Nidacon | Nidacon International AB | 19 |
| Sil-Select Plus Lower Layer | Fertipro NV | 8 |
| FertiCult Mineral Oil | Fertipro NV | 8 |
| Dewin | Donnevie Medical Technology (Shanghai) Co., Ltd. | 8 |
| SpermGrad | Vitrolife Sweden AB | 8 |
| Sequential Culture Media | Kitazato Corporation | 8 |
| Sperm Wash Medium | Invitrocare Inc | 7 |
| Enhance-S Plus | Vitrolife Inc. | 7 |
| G-Vitri™ Vitrification media | Gimbo Medical Technology Shenzhen Co., Ltd. | 7 |
Showing 12 of 360. All products under Media, Reproductive
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170257 | 2017-02-24 |
| K153478 | 2016-08-15 |
| K152717 | 2016-05-06 |
| K160814 | 2016-04-22 |
| K151367 | 2016-01-27 |
| K153290 | 2016-01-27 |
| K152782 | 2015-12-21 |
| K152904 | 2015-12-03 |
| K143724 | 2015-08-27 |
| K082363 | 2009-04-29 |
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.