Icsi Pipette
63 catalogue numbers from 15613, listed by Vitrolife Sweden AB, Sweden, under Microtools, Assisted Reproduction (Pipettes), Exempt. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
63catalogue numbers in this listing
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 | Vitrolife Sweden AB, Sweden |
|---|---|
| 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 | 2022-12-12 |
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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 15613 | 10 | In distribution | |
| 15410 | 10 | In distribution | |
| 15451 | 10 | In distribution | |
| 15445 | 10 | In distribution | |
| 15442 | 10 | In distribution | |
| 15432 | 10 | In distribution | |
| 15358 | 10 | In distribution | |
| 15439 | 10 | In distribution | |
| 15450 | 10 | In distribution | |
| 15543 | 10 | In distribution | |
| 15402 | 10 | In distribution | |
| 15654 | 10 | In distribution | |
| 15433 | 10 | In distribution | |
| 15437 | 10 | In distribution | |
| 15403 | 10 | In distribution | |
| 15435 | 10 | In distribution | |
| 15354 | 10 | In distribution | |
| 15420 | 10 | In distribution | |
| 15404 | 10 | In distribution | |
| 15405 | 10 | In distribution | |
| 15449 | 10 | In distribution | |
| 15344 | 10 | In distribution | |
| 15413 | 10 | In distribution | |
| 15441 | 10 | In distribution | |
| 15448 | 10 | In distribution | |
| 15456 | 10 | In distribution | |
| 15611 | 10 | In distribution | |
| 15653 | 10 | In distribution | |
| 15352 | 10 | In distribution | |
| 15455 | 10 | In distribution | |
| 15429 | 10 | In distribution | |
| 15453 | 10 | In distribution | |
| 15414 | 10 | In distribution | |
| 15436 | 10 | In distribution | |
| 15349 | 10 | In distribution | |
| 15418 | 10 | In distribution | |
| 15440 | 10 | In distribution | |
| 15419 | 10 | In distribution | |
| 15612 | 10 | In distribution | |
| 15406 | 10 | In distribution | |
| 15411 | 10 | In distribution | |
| 15540 | 10 | In distribution | |
| 15444 | 10 | In distribution | |
| 15542 | 10 | In distribution | |
| 15431 | 10 | In distribution | |
| 15401 | 10 | In distribution | |
| 15415 | 10 | In distribution | |
| 15430 | 10 | In distribution | |
| 15342 | 10 | In distribution | |
| 15665 | 10 | In distribution | |
| 15434 | 10 | In distribution | |
| 15409 | 10 | In distribution | |
| 15438 | 10 | In distribution | |
| 15452 | 10 | In distribution | |
| 15412 | 10 | In distribution | |
| 15417 | 10 | In distribution | |
| 15346 | 10 | In distribution | |
| 15541 | 10 | In distribution | |
| 15655 | 10 | In distribution | |
| 15454 | 10 | In distribution | |
| 15446 | 10 | In distribution | |
| 15339 | 10 | In distribution | |
| 15425 | 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 |
| 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 |
| 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.