GDC-18
Fibered VortX Detachable coil
5manufacturers in China registered for this device type
41catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (2), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Microport Neurotech (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | HCG |
| Device type | Device, Neurovascular Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5950 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2015-09-21 |
| Record revised | 2021-02-05 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store in cool, dry, dark place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M00335130440 | Secondary Coil Diameter: 3.0 Millimeter | In distribution |
| M00335520340 | Secondary Coil Diameter: 20.0 Millimeter | In distribution |
| M00334818400 | Coil Length: 40.0 Centimeter | In distribution |
| M00335216340 | Secondary Coil Diameter: 16.0 Millimeter | In distribution |
| M00335262040 | Secondary Coil Diameter: 6.0 Millimeter | In distribution |
| M00335161540 | Secondary Coil Diameter: 6.0 Millimeter | In distribution |
| M00335214340 | Coil Length: 30.0 Centimeter | In distribution |
| M00335518340 | Coil Length: 30.0 Centimeter | In distribution |
| M00335120840 | Coil Length: 8.0 Centimeter | In distribution |
| M00335516340 | Secondary Coil Diameter: 16.0 Millimeter | In distribution |
| M00335210340 | Coil Length: 30.0 Centimeter | In distribution |
| M0033486150 | Secondary Coil Diameter: 6.0 Millimeter | In distribution |
| M00335218340 | Coil Length: 30.0 Centimeter | In distribution |
| M00335302340 | Coil Length: 3.0 Centimeter | In distribution |
| M00335212340 | Secondary Coil Diameter: 12.0 Millimeter | In distribution |
| M00335140640 | Secondary Coil Diameter: 4.0 Millimeter | In distribution |
| M0033488200 | Coil Length: 20.0 Centimeter | In distribution |
| M00335302640 | Coil Length: 11.5 Centimeter | In distribution |
| M00335512340 | Coil Length: 30.0 Centimeter | In distribution |
| M00335582540 | Secondary Coil Diameter: 8.0 Millimeter | In distribution |
| M00335151240 | Coil Length: 12.0 Centimeter | In distribution |
| M00335220340 | Coil Length: 30.0 Centimeter | In distribution |
| M00335514340 | Secondary Coil Diameter: 14.0 Millimeter | In distribution |
| M00335510340 | Secondary Coil Diameter: 10.0 Millimeter | In distribution |
| M00335273040 | Secondary Coil Diameter: 7.0 Millimeter | In distribution |
| M00335141040 | Secondary Coil Diameter: 4.0 Millimeter | In distribution |
| M00334816300 | Coil Length: 30.0 Centimeter | In distribution |
| M00334814300 | Coil Length: 30.0 Centimeter | In distribution |
| M00335150840 | Secondary Coil Diameter: 5.0 Millimeter | In distribution |
| M00335293040 | Secondary Coil Diameter: 9.0 Millimeter | In distribution |
| M00334812300 | Coil Length: 30.0 Centimeter | In distribution |
| M00335161040 | Secondary Coil Diameter: 6.0 Millimeter | In distribution |
| M00335252040 | Secondary Coil Diameter: 5.0 Millimeter | In distribution |
| M00334813300 | Coil Length: 30.0 Centimeter | In distribution |
| M00334810300 | Secondary Coil Diameter: 10.0 Millimeter | In distribution |
| M00335130840 | Coil Length: 8.0 Centimeter | In distribution |
| M00335302540 | Coil Length: 8.0 Centimeter | In distribution |
| M00335302440 | Distal Diameter: 2.0 Millimeter | In distribution |
| M00335561540 | Secondary Coil Diameter: 6.0 Millimeter | In distribution |
| M00335120440 | Coil Length: 4.0 Centimeter | In distribution |
| M00335283040 | Coil Length: 30.0 Centimeter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Optima Coil System | Balt USA, LLC | 307 |
| Penumbra Coil 400 | Penumbra Inc. | 268 |
| Smart Coil | Penumbra Inc. | 238 |
| Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 234 |
| Numen | Microport Neurotech (Shanghai) Co., Ltd. | 223 |
| Axium™ Prime Detachable Coil System | Micro Therapeutics, Inc. | 141 |
| Barricade Coil System | Balt USA, LLC | 137 |
| Numen Helia | Microport Neurotech (Shanghai) Co., Ltd. | 129 |
| V-Trak | MicroVention, Inc. | 106 |
| HydroSoft Helical | MicroVention, Inc. | 94 |
| AxiumTM | Micro Therapeutics, Inc. | 89 |
| LP Coil System | Penumbra Inc. | 77 |
Showing 12 of 99. All products under Device, Neurovascular Embolization
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.