Rocket
Rocket Glass Collection Bottle with bung
4manufacturers in China registered for this device type
6catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (2), Hubei (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Saint-Gobain Life Sciences (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 5 |
| Wuhan Huchuang Union Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 8 |
| HUA YUE Medical Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 7 |
| CGN Gray (Shenzhen) Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
Record
| Listed by | Rocket Medical PLC, United Kingdom |
|---|---|
| FDA product code | MQG |
| Device type | Accessory, Assisted Reproduction |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6120 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K000394 |
| Record published | 2023-10-30 |
| Record revised | 2023-12-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2023-12-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R29655 | In distribution | |
| R28410 | Withdrawn | |
| R29662 | Withdrawn | |
| R28135 | Withdrawn | |
| R29656 | Withdrawn | |
| R28406 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Coda® | LifeGlobal Group, LLC | 42 |
| Thermo Scientific Forma | Thermo Fisher Scientific (Asheville) LLC | 22 |
| Kryo ART Freezer | Planer Limited | 6 |
| Panasonic | PHC Corporation | 6 |
| Cook | William A. Cook Australia PTY, Ltd. | 5 |
| Metiec | Wuhan Huchuang Union Technology Co., Ltd. | 3 |
| BT37 Incubator | Planer Limited | 3 |
| RI Witness | Research Instruments Ltd | 3 |
| Thermo Scientific | Thermo Electron LED GmbH | 2 |
| Multiroom IVF incubator | Esco Medical Technologies, UAB | 2 |
| Kryo 360 Freezer | Planer Limited | 2 |
| PHCbi | PHC Corporation | 2 |
Showing 12 of 41. All products under Accessory, Assisted Reproduction
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K000394 | 2000-02-29 |
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.