Mindray
Disposable Needle Guides Kit for general purpose biopsy(out-of-plane), contents: Needle guide(Out-of-Plane) acceptable needle sizes:20-21G and Biopsy Depth: 5,10,15,25,35mm; 20g gel;…
Disposable Needle Guides Kit for general purpose biopsy(out-of-plane), contents: Needle guide(Out-of-Plane) acceptable needle sizes:20-21G and Biopsy Depth: 5,10,15,25,35mm; 20g gel; 14x100cm TPU cover, rubber bands.
4manufacturers in China registered for this device type
16catalogue numbers in this listing
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Sonoscape Medical Corp. | Shenzhen | Guangdong | Manufacturer | 7 |
| Shenzhen Wisonic Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Jingfang Precision Medical Device(Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Record
| Listed by | Jingfang Precision Medical Device(Shenzhen) Co., Ltd., China |
|---|---|
| FDA product code | OIJ |
| Device type | Biopsy Needle Guide Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1560 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-05-08 |
| Record revised | 2025-07-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 50 to 86 °F; Special storage condition: Keep Away from Sunlight |
| Packaging | Pack of 24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NGB-044-D | In distribution | |
| NGB-066-D | In distribution | |
| NGB-060-D | In distribution | |
| NGB-063-DK | In distribution | |
| NGB-062-D | In distribution | |
| NGB-043-D | In distribution | |
| NGB-058-D | In distribution | |
| DGK-A01-M | In distribution | |
| DGCK-0101-M | In distribution | |
| NGB-051-DK(17/18G) | In distribution | |
| NGB-067-D | In distribution | |
| DGCK-1101-M | In distribution | |
| NGB-057-D | In distribution | |
| NGB-051-DK(15/16G) | In distribution | |
| NGB-054-D | In distribution | |
| NGB-062-DK | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| InnoFine | Jingfang Precision Medical Device(Shenzhen) Co., Ltd. | 531 |
| SonoScape | Sonoscape Medical Corp. | 70 |
| Hitachi | Hitachi, Ltd. | 57 |
| Sheathes | Sheathing Technologies, Inc. | 14 |
| Cardinal Health | Cardinal Health 200, LLC | 12 |
| Sheathes3D | Sheathing Technologies, Inc. | 7 |
| iSR’obot Kit | Biobot Surgical Pte. Ltd. | 4 |
| NGB-007 Needle-guided Bracket | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 2 |
| NGB-011 Needle-guided Bracket | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 2 |
| NGB-022 Needle-guided Bracket | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 2 |
| NGB-018 Needle-guided Bracket | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 2 |
| Moving-Shot Guide | RF Medical Co., Ltd. | 2 |
Showing 12 of 45. All products under Biopsy Needle Guide Kit
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.