Sheathes3D
Seamless Viral Barrier, Polyurethane, 7/8"D Tapered to 2.9"W x 8"L, Non-Sterile, Ultrasound Probe Cover w/3" Debris Shield, Vaginal/Rectal, Bi-Directionally Rolled, Individually Wrapped
44manufacturers in China registered for this device type
78catalogue numbers in this listing
4510(k) clearances naming this product code
1recall
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 | Sheathing Technologies, Inc., United States |
|---|---|
| FDA product code | ITX |
| Device type | Transducer, Ultrasonic, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1570 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K153212 |
| Record published | 2016-09-22 |
| Record revised | 2022-03-22 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 3, case of 6 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 50001-IL2445 | 25 | In distribution | |
| 50040-74244 | 25 | In distribution | |
| 76303 | 75 | In distribution | |
| 50040-IT966 | 10 | In distribution | |
| 50040-IL586 | 10 | In distribution | |
| 80786 | 40 | In distribution | |
| ADH-35-4 | 25 | In distribution | |
| ADH-50040-IL486 | 10 | In distribution | |
| 73459 | 30 | In distribution | |
| ADH-50001-1245 | 25 | In distribution | |
| 75480 | 30 | In distribution | |
| 50040-IL246 | 25 | In distribution | |
| ADH-50040-1245 | 25 | In distribution | |
| 76440 | 20 | In distribution | |
| 76480 | 30 | In distribution | |
| 74001 | 100 | In distribution | |
| 76401 | 40 | In distribution | |
| 75303VCI | 100 | In distribution | |
| 73401 | 40 | In distribution | |
| ADH-50040-IL2445 | 25 | In distribution | |
| 80740 | 25 | In distribution | |
| 73451 | 40 | In distribution | |
| 50040-IL2445 | 25 | In distribution | |
| 50040-IH486 | 25 | In distribution | |
| 50001-1245 | 25 | In distribution | |
| 80080 | 40 | In distribution | |
| ADH-3545 | 25 | In distribution | |
| 50001-IH366 | 25 | In distribution | |
| ADH-50040-IL9645 | 10 | In distribution | |
| 74336 | 75 | In distribution | |
| ADH-3545B | 50 | In distribution | |
| 50001-IL366 | 25 | In distribution | |
| 50040-IL486 | 10 | In distribution | |
| 75401 | 40 | In distribution | |
| 80380 | 50 | In distribution | |
| 74303 | 100 | In distribution | |
| 75340 | 50 | In distribution | |
| 75339VCI | 75 | In distribution | |
| 80301 | 75 | In distribution | |
| 83501 | 50 | In distribution | |
| 50001-2445T | 30 | In distribution | |
| 76339 | 50 | In distribution | |
| 75339 | 75 | In distribution | |
| 80540 | 25 | In distribution | |
| 74339 | 75 | In distribution | |
| 76340 | 50 | In distribution | |
| 83540 | 25 | In distribution | |
| 50040-IL4845 | 25 | In distribution | |
| ADH-50040-IL4845 | 10 | In distribution | |
| 83740 | 25 | In distribution | |
| 50001-IL246NS | 25 | In distribution | |
| ADH-50040-IL246 | 25 | In distribution | |
| ADH-50040-IL966 | 10 | In distribution | |
| 80780 | 40 | In distribution | |
| 80340 | 25 | In distribution | |
| 73540 | 20 | In distribution | |
| ADH-3545-4 | 25 | In distribution | |
| 74040 | 20 | In distribution | |
| 80501 | 50 | In distribution | |
| 75440 | 20 | In distribution | |
| ADH-35B | 50 | In distribution | |
| 74080 | 75 | In distribution | |
| 80040 | 25 | In distribution | |
| 70340VCI | 50 | In distribution | |
| 75303 | 100 | In distribution | |
| 73480 | 30 | In distribution | |
| 80701 | 50 | In distribution | |
| 74340 | 50 | In distribution | |
| 80586 | 40 | In distribution | |
| 83001 | 50 | In distribution | |
| 80580 | 40 | In distribution | |
| 80001 | 50 | In distribution | |
| 50001-74244 | 25 | In distribution | |
| 73440 | 20 | In distribution | |
| 50040-IT964 | 10 | In distribution | |
| ADH-35 | 25 | In distribution | |
| 83701 | 50 | In distribution | |
| ADH-35-EL | 25 | 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 |
| 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 |
| Needle Guide Starter Kit | Civco Medical Instruments Co., Inc. | 52 |
Showing 12 of 1,678. All products under Transducer, Ultrasonic, Diagnostic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153212 | 2016-03-04 |
| K091828 | 2009-09-28 |
| K043425 | 2005-02-28 |
| K990175 | 1999-04-21 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Sheathing Technologies, Inc. | 510(k) number | 2025-11-17 | Class II | Process control | Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk. | 12 |
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.