V-Icsipet Trophectoderm Biopsy
V-ICSIPET is a borosilicate glass micropipette for use in assisted reproduction. The pipettes are available with different tips, inner diameters and angles. V-ICSIPET TROPHECTODERM BIOPSY…
V-ICSIPET is a borosilicate glass micropipette for use in assisted reproduction. The pipettes are available with different tips, inner diameters and angles. V-ICSIPET TROPHECTODERM BIOPSY pipettes are for the collection of trophectoderm cells for subsequent preimplantation genetic diagnosis.
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (1), Hubei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Kangjian Medical Apparatus Co., Ltd. | Jiangyan | Jiangsu | Contract manufacturer | 19 |
| Guangzhou Huada Biotechnology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
| Wuhan Huchuang Union Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 8 |
| Shenzhen VitaVitro Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Guangzhou Pinzhi Medical Device Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 5 |
| UKS Medical Technology (Chongqing) Co., Ltd. | Chongging | Sichuan | Contract manufacturer | 4 |
| Arsci Biomedical Inc. | Jiaxing | Zhejiang | Manufacturer | 2 |
| Donnevie Medical Technology (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 1 |
Record
| Listed by | Vitromed GmbH, Germany |
|---|---|
| FDA product code | PUC |
| Device type | Microtools, Assisted Reproduction (Pipettes), Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6130 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-03-01 |
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 |
|---|---|---|---|
| V-ICSIPET Trophectoderm Biopsy 30 | 10 | In distribution | |
| V-ICSIPET Trophectoderm Biopsy 20 | 10 | In distribution | |
| V-ICSIPET Trophectoderm Biopsy 30 | 10 | In distribution | |
| V-ICSIPET Trophectoderm Biopsy 20 | 10 | In distribution | |
| V-ICSIPET Trophectoderm Biopsy 25 | 10 | In distribution | |
| V-ICSIPET Trophectoderm Biopsy 35 | 10 | In distribution | |
| V-ICSIPET Trophectoderm Biopsy 35 | 10 | In distribution | |
| V-ICSIPET Trophectoderm Biopsy 25 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sunbiotec | Hubei Huamei Sunlight Biotechnologies Co., Ltd. | 435 |
| SLM | Sunlight Medical, Inc. | 303 |
| TPC | Coopersurgical, Inc. | 91 |
| Icsi Pipette | Vitrolife Sweden AB | 63 |
| Astec | Astec BIO USA Inc | 52 |
| Biopsy Pipette | Vitrolife Sweden AB | 34 |
| Kitazato Injection Micropipette | Kitazato Corporation | 25 |
| Holding Pipette | Vitrolife Sweden AB | 23 |
| Dewin | Donnevie Medical Technology (Shanghai) Co., Ltd. | 21 |
| Brilliant Biopsy Micropipette | Hamilton Thorne, Inc. | 14 |
| Intelligent Icsi Micropipette | Hamilton Thorne, Inc. | 13 |
| SFG Denuding pipettes | Spectrum Fertility Group Inc. | 12 |
Showing 12 of 38. All products under Microtools, Assisted Reproduction (Pipettes), Exempt
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.