FDA Registration
Active
🇬🇧 United Kingdom
ROCKET MEDICAL PLC
Reg #: 9610632
·
FEI: 3002808026
·
Expires 2026
Products
16
Proprietary Names
58
Establishment Types
2
Classifications
16
Registration Details
- Registration Name
- ROCKET MEDICAL PLC
- Registration Number
- 9610632
- FEI Number
- 3002808026
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Sedling Road
- City
- WASHINGTON Sunderland
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K994327
Owner / Operator
- Firm Name
- Rocket Medical Plc
- Operator Number
- 8010022
- Address
- Sedling Road, --
- City
- Washington
- State
- Sunderland
- Postal Code
- NE38 9BZ
- Country
- GB
US Agent
- Business Name
- Rocket Medical LLC
- Contact Name
- Toby Tyson
- Address
- 50 Corporate Park Drive, Suite 890
- City
- Pembroke
- State
- MA
- ZIP
- 02359
- Country
- US
- [email protected]
- Phone
- 781 7496223
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Assisted Reproduction | MQF | Class 2 | Obstetrics/Gynecology | No | 2007-11-27 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2015-08-19 |
| Bulb, Inflation, For Endoscope | FCY | Class 1 | Gastroenterology, Urology | No | 2014-05-28 |
| Needle, Assisted Reproduction | MQE | Class 2 | Obstetrics/Gynecology | No | 2007-11-27 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2007-11-27 |
| Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling | PNG | Class 2 | Gastroenterology, Urology | No | 2016-04-20 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2008-07-10 |
| Tubing And Tubing/Filter Fits | NVT | Class 1 | Obstetrics/Gynecology | No | 2007-11-27 |
| Accessory, Assisted Reproduction | MQG | Class 2 | Obstetrics/Gynecology | No | 2007-11-27 |
| Electrode, Circular (Spiral), Scalp And Applicator | HGP | Class 2 | Obstetrics/Gynecology | No | 2007-02-21 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 1997-09-22 |
| Chest Drainage Kit | PAD | Class 2 | General Hospital | No | 2019-08-12 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2022-01-19 |
| Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) | HES | Class 2 | Obstetrics/Gynecology | No | 2007-11-27 |
| Apparatus, Suction, Patient Care | DWM | Class 2 | Cardiovascular | No | 2013-02-11 |
| Cannula, Intrauterine Insemination | MFD | Class 2 | Obstetrics/Gynecology | No | 2007-11-27 |
Proprietary Names
ET Catheters
#K994327
For the placement of embryos
Heimlich Valve
IPC Bottles and accessories
Pleural Vent
R53902 Disposable Sigmoidoscope Insufflation Sets
Rocket Medical Needle Guides
Rocket Peritoneal Catheter & Accessories
Thoracentesis
Seldinger Chest Drain Kit
R54544-12-00 / 18-00 etc
Thoracic Catheters
Pleural Drain Set
Needle Drains
Blunt Dissection Kits
R58800 Range - Drainage Catheters
Chest Aspiration Set
IVF Devices
Aspiration & Collection
#K000205
R57687 Filter Set for Cook K-MAR 5200 Pump
R57685 Water Trap Set for CRAFT Suction Pumps
R57686 Filter Set for Oocyte Aspiration Pump
#K000394
R29660 CRAFT DUO VAC Suction Pump (240V)
R29661 CRAFT DUO VAC Suction Pump (110v)
R57008-00-CN Copeland Foetal Scalp Electrode for Qwik Connect Cables
#K844608
R57008-00-FM Copeland Foetal Scalp Electrode for Philips Avalon Cables
#K972867
R29654 CRAFT Suction Pump (110v)
R29655 CRAFT Suction Pumps (240V)
R51401-DP
R51411-00-PP
R51401
R51411
R51401-00-PP
R51400-00-PP
R51400-DP
R51400
Drainage Bottle
#K000340
R57422-00-PK HSG Procedure Pack 5Fg
R57424-00-PK HSG Procedure Pack 7Fg
R57422 HSG & HyCoSy Catheter 5Fg
R57430-CONE Hysterocone - 6Fg HSG & HyCoSy Catheter
R57422-ST-PK HSG Procedure Pack - 5Fg with Stylet
R57424 HSG & HyCoSy Catheter 7Fg
R57422-00-ST HSG & HyCoSy Catheter with Stylet 5Fg
R57424-ST-PK HSG Procedure Pack - 7Fg with Stylet
R57424-00-ST HSG & HyCoSy Catheter with Stylet 7Fg
Rocket Indwelling Pleural Catheter (IPC) System
Including Bottles, bags, insertion sets
#K980061
R57625 Embryon DUO IUI Catheter 18cm
R57625-00-23 Embryo DUO IUI Catheter 23cm
R57622 Embryon EDL IUI Catheter 18cm
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device