Philips
Lateral Grid, Upper dS Breast 16CH I/T
32manufacturers in China registered for this device type
31catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (11), Zhejiang (8), Jiangsu (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Wanying Health & Technology (Zhongshan) Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 3 |
| Zhejiang Solong Electromechanical Limited | Pujiang | Zhejiang | Contract manufacturer | 3 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai Dochem Industries Co., Ltd. | Shanghai | Shanghai | Manufacturer | 45 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
Showing 12 of 32. All 32 manufacturers in China registered for Guide, Needle, Surgical
Record
| Listed by | Philips Medical Systems Nederland B.V., Netherlands |
|---|---|
| FDA product code | GDF |
| Device type | Guide, Needle, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-07-18 |
| Record revised | 2025-09-29 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Liquid Chemical |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment humidity 30 to 75 % RH; Storage environment temperature 15 to 30 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Grid Immobilization Plate LBS M-L | In distribution | ||
| Pillar Immobilization Plate BBC | In distribution | ||
| Fiducial Marker Grid Block Assembly | In distribution | ||
| Pillar Immobilization Plate LBS M-L | In distribution | ||
| Needle Block 12G | In distribution | ||
| Grid Plate Enhanced Access, Lateral | In distribution | ||
| Fiducial Holder | In distribution | ||
| Pillar Immobilization Plate BBC | In distribution | ||
| Grid Immobilization Plate OBC | In distribution | ||
| Needle Sleeve 16G | In distribution | ||
| Needle Block 8G | In distribution | ||
| Needle Sleeve 12G | In distribution | ||
| Medial Grid dS Breast 16CH 1/T | In distribution | ||
| LATERAL GRID, UPPER dS BREAST 16CH I/T | In distribution | ||
| LATERAL GRID, LOWER dS BREAST 16CH I/T | In distribution | ||
| Pillar Immobilization Plate LBS C-C | In distribution | ||
| Needle Block Holder | In distribution | ||
| Fiducial Marker Sleeve Assembly | In distribution | ||
| Needle Sleeve 14G | In distribution | ||
| Needle Hub Assembly | In distribution | ||
| Breast Grid (User-Sterilized) | 14 | In distribution | |
| Biopsy Grid, Sterilized | 10 | In distribution | |
| Pillar Immobilization Plate | In distribution | ||
| Needle Block 18G | In distribution | ||
| Grid Immobilization Plate LBS C-C | In distribution | ||
| Needle Block 16G | In distribution | ||
| Needle Sleeve 18G | In distribution | ||
| Grid Immobilization Plate BBC | In distribution | ||
| Grid Plate, Enhanced Access Medial | In distribution | ||
| Lateral Grid dS Breast 16CH I/T | In distribution | ||
| Needle Block 14G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Needle Holder | Koros U.S.A., Inc. | 175 |
| Stoma® | Storz AM Mark Gmbh | 63 |
| Aptus | Medartis Inc. | 62 |
| Temno | Carefusion 2200, Inc. | 31 |
| MaxMoreSpine | Hoogland Spine Products GmbH | 23 |
| Silex Sacroiliac Joint Fusion System | Xtant Medical Holdings, Inc. | 20 |
| Biopsybell | Biopsybell SRL | 16 |
| Arterial Needle | Argon Medical Devices, Inc. | 14 |
| Ghiatas® | Bard Peripheral Vascular, Inc. | 14 |
| Sklar® | Sklar Corporation | 14 |
| Leap Med | Advance Medical Designs, Inc. | 14 |
| Gimmi | Gimmi Gmbh | 11 |
Showing 12 of 169. All products under Guide, Needle, Surgical
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.