Microtools (Biopsy Pipette)
A non-invasive, single-use micro-manipulation pipette used in the laboratory to inject, denude, mobilize, remove, aspirate, incise, manipulate or separate cells for the duration of In-Vitro…
A non-invasive, single-use micro-manipulation pipette used in the laboratory to inject, denude, mobilize, remove, aspirate, incise, manipulate or separate cells for the duration of In-Vitro Fertilization (IVF), Assisted Reproductive Technologies (ART), and Reproductive Medicine (RM) procedures. The Biopsy Pipette is to be used by qualified personnel during In-Vitro Fertilization (IVF) or Assisted Reproduction Technology (ART) procedures in vitro, to aspirate or remove blastomere(s) from a developing embryo for pre-implantation genetic diagnosis (PGD) on the genetic material in the biopsied cell(s). Intended for one-time use.
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Huada Biotechnology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
| Guangzhou Pinzhi Medical Device Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 5 |
Record
| Listed by | Arsci Inc., Canada |
|---|---|
| FDA product code | MQH |
| Device type | Microtools, Assisted Reproduction (Pipettes) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6130 |
| Establishment | Manufacturer |
| 510(k) | K102480 |
| Record published | 2022-10-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| B-35FP04 | 10 | In distribution | |
| B-30FP01 | 10 | In distribution | |
| B-30FP05 | 10 | In distribution | |
| B-30FP04 | 10 | In distribution | |
| B-30FP02 | 10 | In distribution | |
| B-30BP01 | 10 | In distribution | |
| B-35FP01 | 10 | In distribution | |
| B-35BP01 | 10 | In distribution | |
| B-35FP05 | 10 | In distribution | |
| B-35FP02 | 10 | In distribution | |
| B-35FP03 | 10 | In distribution | |
| B-30FP03 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Wallace | ICU Medical, Inc | 452 |
| Microtools, Assisted Reproduction (Pipettes) | Origio, Inc. | 264 |
| RI Pipettes | Research Instruments Ltd | 201 |
| Icsi Pipette | Vitrolife Inc. | 75 |
| Biopsy Pipette | Vitrolife Inc. | 38 |
| EZ-Tip | Coopersurgical, Inc. | 29 |
| EZ-Tip | Research Instruments Ltd | 29 |
| Stripper | Origio, Inc. | 27 |
| Holding Pipette | Vitrolife Inc. | 25 |
| Cook | Cook Vandergrift Inc. | 15 |
| Hatching Pipette | Vitrolife Inc. | 15 |
| Cook Flexipet | Cook Vandergrift Inc. | 12 |
Showing 12 of 38. All products under Microtools, Assisted Reproduction (Pipettes)
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.