Sterile Disposable Endocavity Needle Guide
Sterile Disposable Endocavity Needle Guide for use with Esaote EC123, EC1123, SE3123, SE3133, TRT12 & IVT12, GE Healthcare IC5-9-RS & IC5-9W-RS, Philips E6509, Siemens BE9-4, Samsung…
Sterile Disposable Endocavity Needle Guide for use with Esaote EC123, EC1123, SE3123, SE3133, TRT12 & IVT12, GE Healthcare IC5-9-RS & IC5-9W-RS, Philips E6509, Siemens BE9-4, Samsung Medison BCC4-9, Pie Medical C7-4R8TRD and Terason 8EC4 Ultrasound Transducers
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) | K971115 |
| Record published | 2019-03-29 |
| Record revised | 2024-02-16 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5590 | In distribution | |
| 5585 | In distribution | |
| 5505 | In distribution | |
| 5070 | In distribution | |
| 5580 | In distribution | |
| 5480 | In distribution | |
| 5550 | In distribution | |
| 5560 | In distribution | |
| 5250 | In distribution | |
| 5555 | In distribution | |
| 5655 | In distribution | |
| 5665 | In distribution | |
| 5285 | In distribution | |
| 5154 | In distribution | |
| 5144 | In distribution | |
| 5380 | In distribution | |
| 5145 | In distribution | |
| 5270 | In distribution | |
| 5570 | In distribution | |
| 5370 | In distribution | |
| 5531 | In distribution | |
| 5595 | In distribution | |
| 5455 | In distribution | |
| 5565 | In distribution | |
| 5174 | In distribution | |
| 5650 | In distribution | |
| 5142 | In distribution | |
| 5295 | In distribution | |
| 5395 | In distribution | |
| 5575 | In distribution | |
| 5275 | In distribution | |
| 5390 | In distribution | |
| 5260 | In distribution | |
| 5281 | In distribution |
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.