Exact Medical Manufacturing, Inc.
General Purpose Sterile Probe Cover, 6” x 96” with Sterile Gel and Bands
44manufacturers in China registered for this device type
42catalogue numbers in this listing
2510(k) clearances naming this product code
18recalls on this code
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 | Exact Medical Manufacturing, Inc., China |
|---|---|
| FDA product code | ITX |
| Device type | Transducer, Ultrasonic, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1570 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K211969 |
| Record published | 2025-03-26 |
| Record revised | 2024-10-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 3, inner case of 20, case of 60, inner case of 10, case of 100, case of 80 |
| Distribution end date | 2024-10-03 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PC1922-55 | In distribution | |
| TMPH-2002 | In distribution | |
| 1006664 | In distribution | |
| VPC1648 | In distribution | |
| E6381 | In distribution | |
| E6377 | In distribution | |
| E6479 | In distribution | |
| VPG1396 | In distribution | |
| E6485 | In distribution | |
| AMC-A7011 | In distribution | |
| AMC-A7005 | In distribution | |
| ProbeCoverPolyurethane-L-1 | In distribution | |
| ProbeCoverPolyurethane-H-1 | In distribution | |
| MM2000 | In distribution | |
| E6446A | In distribution | |
| VPC0695 | In distribution | |
| VPC0117 | In distribution | |
| 111460 | In distribution | |
| AMC-E6448 | In distribution | |
| PC0696 | In distribution | |
| VPC0695 | In distribution | |
| TMPH-2000 | In distribution | |
| PS-6000 | In distribution | |
| VPC0596 | In distribution | |
| E6380 | In distribution | |
| E6361 | In distribution | |
| E6480 | In distribution | |
| VPC0698 | In distribution | |
| E6458 | In distribution | |
| PC1924-2 | In distribution | |
| E6463 | In distribution | |
| AMC-E6434A | In distribution | |
| VPC0548 | In distribution | |
| E6459 | In distribution | |
| MM2001 | In distribution | |
| 111460 | Withdrawn | |
| DEF1088 | Withdrawn | |
| DEF2630 | Withdrawn | |
| DEF2409 | Withdrawn | |
| DEF648 | Withdrawn | |
| DEF643 | Withdrawn | |
| E6451 | 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 |
|---|---|
| K222460 | 2023-05-12 |
| K211969 | 2021-08-13 |
Recalls
18 of these are Class II. Class II means a temporary or reversible health consequence. 18 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 800 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 7920 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 10020 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 500 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 17545 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 9680 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 3000 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 36000 | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 6000 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 12650 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 100600 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 1600 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 5621 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 78000 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 129600 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 51300 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 33250 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 8800 units | 2022-05-26 |
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.