VitriGuard
VitriGuard Lime Green- 20 x 1 pouch per box
10manufacturers in China registered for this device type
16catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (8), Hubei (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Boomingshing Medical Device Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Shenzhen JPY ION-Tech. Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Wuhan Huchuang Union Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 8 |
| Shenzhen VitaVitro Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| HUA YUE Medical Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 7 |
| CGN Gray (Shenzhen) Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Gimbo Medical Technology Shenzhen Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
| Guangzhou Hehong Biotech Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 2 |
| Shandong Wego Ruisheng Medical Device Co., Ltd. | Weihai | Shandong | Manufacturer | 2 |
Record
| Listed by | Origio A/S, Denmark |
|---|---|
| FDA product code | MQK |
| Device type | Labware, Assisted Reproduction |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6160 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2017-12-17 |
| Record revised | 2018-10-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 43815005 | 10 | In distribution | |
| 43852001 | 20 | In distribution | |
| 43812001 | 20 | In distribution | |
| 43842001 | 20 | In distribution | |
| 43825005 | 10 | In distribution | |
| 43792001 | 20 | In distribution | |
| 43855005 | 10 | In distribution | |
| 43782001 | 20 | In distribution | |
| 43795005 | 10 | In distribution | |
| 43805005 | 10 | In distribution | |
| 43845005 | 10 | In distribution | |
| 43822001 | 20 | In distribution | |
| 43862001 | 20 | In distribution | |
| 43785005 | 10 | In distribution | |
| 43865005 | 10 | In distribution | |
| 43802001 | 20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cryotec | Reprolife Inc. | 20 |
| G-Vitri™ Vitrification Straw | Gimbo Medical Technology Shenzhen Co., Ltd. | 15 |
| ZyMot | DxNow Inc. | 10 |
| LensHooke Sperm Separation Device | Bonraybio Co., Ltd. | 9 |
| cryo-GO Vitrification Device | Fujifilm Irvine Scientific | 9 |
| LifeGlobal® GPS® Dishware | Coopersurgical, Inc. | 7 |
| LifeGlobal® GPS® Dishware | LifeGlobal Group, LLC | 7 |
| Nest VT | Cook Incorporated | 5 |
| Surestrip | Allwin Medical Devices, Inc. | 5 |
| Minvitro Vitrification Straw | Guangzhou Hehong Biotech Co., Ltd. | 5 |
| Rapid-i Kit | Vitrolife Sweden AB | 5 |
| Surelock | Allwin Medical Devices, Inc. | 5 |
Showing 12 of 102. All products under Labware, Assisted Reproduction
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200815 | 2020-06-25 |
| K180740 | 2018-05-04 |
| K162833 | 2017-02-16 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Coopersurgical, Inc. | UDI-DI | 2022-04-01 | Class II | Process control | Products in this lot may have compromised barrier seals, introducing a risk to sterility. | 2,340 (US only) |
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.