Cook
Testicular Sperm Extraction Pipette
2manufacturers in China registered for this device type
5catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Cook Incorporated, United States |
|---|---|
| FDA product code | MQH |
| Device type | Microtools, Assisted Reproduction (Pipettes) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6130 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
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: Store in dark, dry, cool place. |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G32790 | In distribution | |
| G32822 | In distribution | |
| G18095 | In distribution | |
| G32823 | In distribution | |
| G32794 | 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)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151018 | 2016-01-08 |
| K150748 | 2015-12-18 |
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.