Dewin
Micromanipulation pipette is a disposable sterile product made of borosilicate glass for in vitro cell manipulation.The D-HPZD pipette is used to cut an opening on the zona pellucida…
Micromanipulation pipette is a disposable sterile product made of borosilicate glass for in vitro cell manipulation.The D-HPZD pipette is used to cut an opening on the zona pellucida mechanically to enable assisted hatching and/or embryo biopsy.
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 | Donnevie Medical Technology (Shanghai) Co., Ltd., China |
|---|---|
| FDA product code | PUC |
| Device type | Microtools, Assisted Reproduction (Pipettes), Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6130 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-09-12 |
| Record revised | 2023-05-23 (version 3) |
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, manufacturing date |
| Storage | Special storage condition: The micromanipulation pipette should be stored in a dry, ventilated environment away from light. It should be handled wi |
| Packaging | Box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D-HOLD | In distribution | |
| D-HOLD | In distribution | |
| D-ICSI | In distribution | |
| D-DENU | In distribution | |
| D-ICSI | In distribution | |
| D-HOLD | In distribution | |
| D-ICSI | In distribution | |
| D-BIOX | In distribution | |
| D-HPZD | In distribution | |
| D-ICSI | In distribution | |
| D-HOLD | In distribution | |
| D-BIOX | In distribution | |
| D-BIOX | In distribution | |
| D-HOLD | In distribution | |
| D-BIOX | In distribution | |
| D-BIOX | In distribution | |
| D-HOLD | In distribution | |
| D-BIOX | In distribution | |
| D-DENU | In distribution | |
| D-ICSI | In distribution | |
| D-BIOX | 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 |
| Brilliant Biopsy Micropipette | Hamilton Thorne, Inc. | 14 |
| Intelligent Icsi Micropipette | Hamilton Thorne, Inc. | 13 |
| SFG Denuding pipettes | Spectrum Fertility Group Inc. | 12 |
| SFG Biopsy pipettes | Spectrum Fertility Group Inc. | 10 |
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.