Sterile Disposable Endocavity Needle Guide Kit
Sterile Disposable Endocavity Needle Guide Kit for use with: Chison D7C10L & V7-E, Esaote E8-5 R10, International Biomedical E717, Kretz PB-ER4-9ES, Mindray EV6.5 MHZ/R10, 6CV1, 6CV1s,…
Sterile Disposable Endocavity Needle Guide Kit for use with: Chison D7C10L & V7-E, Esaote E8-5 R10, International Biomedical E717, Kretz PB-ER4-9ES, Mindray EV6.5 MHZ/R10, 6CV1, 6CV1s, 65EC10EA, 65EC10EB, 65EC10HA, CB10-4, CB10-HS, V10-4, V10-4B, V10-4BS, V10-4S, V11-3E, V11-3WE & V11-3WS,Samsung Medison EC4-9IS, EC4-9ES, ER4-9ES, & 10R EV/140D, Siemens 6.5 EC10, EC7, EC9-4 (Sonoline G20, G50S & Acuson X500 Ultrasound Systems), & EV9-4 (Acuson X500 Ultrasound System), Supersonic Imagine SuperEndocavity SE12-3 & SEV12-3, Terason 8EC4(V), Vermon E710, and Zonare E9-3
Who Else Makes It
Concentrated in Guangdong (18), Jiangsu (10), Shanghai (3). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Ming FAI Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Xuzhou Yongkang Electronic Science Technology Co., Ltd. | Xuzhou | Jiangsu | Contract manufacturer | 13 |
| Hony Medical Co., Ltd. | Taishan | Guangdong | Contract manufacturer | 10 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| Philips Ultrasound (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Showing 12 of 44. All 44 manufacturers in China registered for Transducer, Ultrasonic, Diagnostic
Record
| Listed by | Protek Medical Products, Inc., United States |
|---|---|
| FDA product code | ITX |
| Device type | Transducer, Ultrasonic, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1570 |
| 510(k) | K970893 |
| Record published | 2020-03-13 |
| Record revised | 2024-02-16 (version 12) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 24 |
| Distribution end date | 2017-04-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5535 | In distribution | |
| 9005 | In distribution | |
| 5146 | In distribution | |
| 5552 | In distribution | |
| 5388 | In distribution | |
| 5267 | In distribution | |
| 5261 | In distribution | |
| 5373 | In distribution | |
| 5280 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SonoScape | Sonoscape Medical Corp. | 302 |
| Biopsy Starter Kit | Civco Medical Instruments Co., Inc. | 172 |
| Sheathes | Sheathing Technologies, Inc. | 170 |
| Needle Guide | Civco Medical Instruments Co., Inc. | 156 |
| Sheathes3D | Sheathing Technologies, Inc. | 78 |
| Ultrasound Probe Cover Biopsy Needle Guide | Advance Medical Designs, Inc. | 78 |
| ultrasonic transducer | Edan Instruments, Inc. | 70 |
| Unbranded | Advance Medical Designs, Inc. | 68 |
| Reusable Biopsy Bracket | Protek Medical Products, Inc. | 60 |
| Ultrasound Probe Cover Biopsy Needle Guide Kit | Advance Medical Designs, Inc. | 58 |
| Biopsy Bracket | Civco Medical Instruments Co., Inc. | 56 |
| Transducer Cover | Civco Medical Instruments Co., Inc. | 54 |
Showing 12 of 1,678. All products under Transducer, Ultrasonic, Diagnostic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K973958 | 1998-01-22 |
| K973622 | 1997-11-26 |
| K973362 | 1997-10-01 |
| K971722 | 1997-07-10 |
| K971115 | 1997-06-13 |
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.