Microtools (Denuding 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 Denuding Pipette is to be used by qualified personnel during In-Vitro Fertilization (IVF) or Assisted Reproduction Technology (ART) procedures in vitro, for the removal or separation of cumulus cells from the oocyte. The Denuding Pipette is also used for transferring oocytes, blastomeres, and embryos. 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 |
|---|---|---|---|
| D-200 | 50 | In distribution | |
| D-190 | 50 | In distribution | |
| D-160 | 50 | In distribution | |
| D-170 | 50 | In distribution | |
| D-140 | 50 | In distribution | |
| D-220 | 50 | In distribution | |
| D-180 | 50 | In distribution | |
| D-120 | 50 | In distribution | |
| D-130 | 50 | In distribution | |
| D-250 | 50 | In distribution | |
| D-150 | 50 | 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.