Hitachi
Puncture Guide Fixture
4manufacturers in China registered for this device type
57catalogue 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 | Hitachi, Ltd., United States |
|---|---|
| FDA product code | OIJ |
| Device type | Biopsy Needle Guide Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1560 |
| 510(k) | K083254 |
| Record published | 2018-09-23 |
| Record revised | 2022-06-17 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Sizes | Needle gauge 12 to 25 G; angle 25 ° |
| Distribution end date | 2021-06-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EZU-PA5O-21 | Needle Gauge 21 G | Withdrawn |
| MP-2783-G22 | Needle Gauge 22 G | Withdrawn |
| EZU-PA5C4 | Withdrawn | |
| EZU-PA5O-14 | Needle Gauge 14 G | Withdrawn |
| EZU-PA5O-18 | Needle Gauge 18 G | Withdrawn |
| MP-2452-G14 | Needle Gauge 14 G | Withdrawn |
| MP-2824 | Withdrawn | |
| MP-2785-G23 | Needle Gauge 23 G | Withdrawn |
| MP-2785-G16 | Needle Gauge 16 G | Withdrawn |
| MP-2781-25 | Angle 25 ° | Withdrawn |
| MP-2794-G20/21 | Needle Gauge 21 G | Withdrawn |
| MP-2452-G18 | Needle Gauge 18 G | Withdrawn |
| MP-2785-G18 | Needle Gauge 18 G | Withdrawn |
| MP-2748-G18 | Needle Gauge 18 G | Withdrawn |
| MP-2785-G19 | Needle Gauge 19 G | Withdrawn |
| MP-2748-G14 | Needle Gauge 14 G | Withdrawn |
| MP-2445-G18 | Needle Gauge 18 G | Withdrawn |
| MP-2785-G17 | Needle Gauge 17 G | Withdrawn |
| MP-2445-G14 | Needle Gauge 14 G | Withdrawn |
| MP-2771-G18 | Needle Gauge 18 G | Withdrawn |
| MP-2445-G19 | Needle Gauge 19 G | Withdrawn |
| MP-2781 | Withdrawn | |
| EZU-PA5C1 | Withdrawn | |
| MP-2785-G13 | Needle Gauge 13 G | Withdrawn |
| MP-2785-G21 | Needle Gauge 21 G | Withdrawn |
| MP-2450 | Withdrawn | |
| MP-2445-G17 | Needle Gauge 17 G | Withdrawn |
| MP-2456 | Withdrawn | |
| MP-2783 | Withdrawn | |
| MP-2794-G18 | Needle Gauge 18 G | Withdrawn |
| MP-2794-G16 | Needle Gauge 16 G | Withdrawn |
| MP-2448 | Withdrawn | |
| MP-2785-G25 | Needle Gauge 25 G | Withdrawn |
| MP-2794-G14 | Needle Gauge 14 G | Withdrawn |
| BA-001 | Withdrawn | |
| MP-2771-G16 | Needle Gauge 16 G | Withdrawn |
| EZU-PA3U | Withdrawn | |
| MP-2748-G17 | Needle Gauge 17 G | Withdrawn |
| MP-2748-SET | Withdrawn | |
| MP-2445-SET | Withdrawn | |
| MP-2452-G21 | Needle Gauge 21 G | Withdrawn |
| MP-2785-G12 | Needle Gauge 12 G | Withdrawn |
| MP-2748-G16 | Needle Gauge 16 G | Withdrawn |
| MP-2458 | Withdrawn | |
| MP-2748-G22 | Needle Gauge 22 G | Withdrawn |
| EZU-PA532 | Withdrawn | |
| MP-2785-G20 | Needle Gauge 20 G | Withdrawn |
| MP-2785-G14 | Needle Gauge 14 G | Withdrawn |
| MP-2445-G22 | Needle Gauge 22 G | Withdrawn |
| MP-2748-G19 | Needle Gauge 19 G | Withdrawn |
| MP-2785-G22 | Needle Gauge 22 G | Withdrawn |
| MP-2445-G16 | Needle Gauge 16 G | Withdrawn |
| MP-2473 | Withdrawn | |
| MP-2445-G20/21 | Needle Gauge 21 G | Withdrawn |
| MP-2785-G15 | Needle Gauge 15 G | Withdrawn |
| MP-2452-G16 | Needle Gauge 16 G | Withdrawn |
| MP-2408B | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| InnoFine | Jingfang Precision Medical Device(Shenzhen) Co., Ltd. | 531 |
| SonoScape | Sonoscape Medical Corp. | 70 |
| Mindray | Jingfang Precision Medical Device(Shenzhen) Co., Ltd. | 16 |
| 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.