FDA Registration
Active
🇬🇧 United Kingdom
Purple Surgical Manufacturing Limited
Reg #: 3008571754
·
FEI: 3008571754
·
Expires 2026
Products
15
Proprietary Names
29
Establishment Types
2
Classifications
15
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Registration Details
- Registration Name
- Purple Surgical Manufacturing Limited
- Registration Number
- 3008571754
- FEI Number
- 3008571754
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Culmhead Business Centre, Culmhead
- City
- Taunton Somerset
- Country
- GB
Owner / Operator
- Firm Name
- Purple Surgical International Limited
- Operator Number
- 10033672
- Address
- 2 Chestnut House, Farm Close, Shenley
- City
- Herts
- State
- England
- Postal Code
- WD7 9AD
- Country
- GB
US Agent
- Business Name
- mdi Consultants, Inc.
- Contact Name
- Alan Schwartz
- Address
- 55 Northern Blvd.
- City
- Great Neck
- State
- NY
- ZIP
- 11021
- Country
- US
- [email protected]
- Phone
- 516 4829001
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2010-12-01 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2010-12-01 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2017-01-10 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2016-11-08 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2010-09-13 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2010-09-13 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2010-09-13 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2010-12-01 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2010-12-01 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2019-11-19 |
| Anti Fog Solution And Accessories, Endoscopy | OCT | Class 2 | Gastroenterology, Urology | No | 2019-05-08 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2011-03-15 |
| Infusor, Pressure, For I.V. Bags | KZD | Class 1 | General Hospital | No | 2012-04-24 |
| Bag, Intestine | KGY | Class 1 | General, Plastic Surgery | No | 2010-12-01 |
| Cannula, Manipulator/Injector, Uterine | LKF | Class 2 | Obstetrics/Gynecology | No | 2010-12-01 |
Proprietary Names
Insufflation Filter Tubing Sets - Various names and models
PS3600, PS3601, PS3602, PS3603, PS3604, PS3605
PS6204 Curette Flexible 4 mm PS6205 Curette Flexible, 5 mm PS6206 Curette Flexible 6 mm, PS6207 Curette Flexible 7 mm
PS6208 Curette Flexible 8 mm, PS6210 Curette Flexible 10 mm, PS6212 Curette Flexible 12 mm
PS6010 Curette, Rigid, Straight 10 mm, PS6011 Curette, Rigid, Straight 11 mm, PS6012 Curette, Rigid, Straight 12 mm
PS6007 Curette, Rigid, Straight 7 mm, PS6008 Curette, Rigid, Straight 8 mm, PS6009 Curette, Rigid, Straight 9 mm
PS6107 Curette, Rigid, Curved 7 mm, PS6108 Curette, Rigid, Curved 8 mm, PS6109 Curette, Rigid, Curved 9 mm
PS6110 Curette, Rigid, Curved 10 mm, PS6111 Curette, Rigid, Curved 11 mm, PS6112 Curette, Rigid, Curved 12 mm
PS6100
Model Number: PS3852ULT
& Laparascopic Accessories
Purple Surgical International Ltd Disposable Trocar
Laparoscopic Blunt Tip Disector 5 x 41cm Single Use
PS3885, PS3886 Various names and models
Camera Sleeve - Various names and models
PS3900
Tissue Trap filter with adaptor
5mm Laparoscopic Electrodes
Monopolar Cables
Mr. Clear
Various names and Models
Aspiration Needle (PS3895)
PS3871 Irrigation Pump
Endo Retrieval Pouches - Various names and models
PS3400, PS3401
Tissue Retrieval Pouches - Various names and models
ElectroLube
PS3111
Uterine Manipulator - Various names and models
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device