Bard® SkyLite™ Tipless Nitinol Stone Basket
2.4Fr Nitinol Tipless Basket
21manufacturers in China registered for this device type
3catalogue numbers in this listing
2510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (8), Guangdong (5), Zhejiang (4). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Changzhou Health Microport Medical Device Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
Showing 12 of 21. All 21 manufacturers in China registered for Dislodger, Stone, Basket, Ureteral, Metal
Record
| Listed by | C.R. Bard, Inc., United States |
|---|---|
| FDA product code | FFL |
| Device type | Dislodger, Stone, Basket, Ureteral, Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4680 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-08-06 |
| Record revised | 2020-11-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 15 |
| Sizes | Length 120 cm; catheter gauge 1.9 to 3 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 042400 | Length 120 cm | In distribution |
| 043000 | Length 120 cm | In distribution |
| 041900 | Catheter Gauge 1.9 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Gemini | Boston Scientific Corporation | 25 |
| V. Mueller | Carefusion 2200, Inc. | 23 |
| Porges Coloplast | Coloplast A/S | 23 |
| Seplou | Seplou (Zhuhai) Co., Ltd. | 22 |
| Captura | Cook Incorporated | 18 |
| Memory Basket | Cook Incorporated | 17 |
| Cook | Cook Incorporated | 17 |
| NCircle | Cook Incorporated | 12 |
| Tricep | Boston Scientific Corporation | 10 |
| Segura Hemisphere | Boston Scientific Corporation | 9 |
| Greenwald Surgical Company, Inc. | Grace Manufacturing Inc | 9 |
| Disposable Retrieval Basket | TeleMed Systems | 8 |
Showing 12 of 112. All products under Dislodger, Stone, Basket, Ureteral, Metal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K961248 | 1996-05-28 |
| K921233 | 1992-04-27 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-10-07 | Class II | Release of Material/Component prior to receiving test results | The product is non-sterile. | 86 units | 2015-06-12 |
| 2003-12-22 | Not classified | Other | Product packaging may contain holes compromising sterility. | 12,684 units (total includes both types) | 2004-09-01 |
| 2003-12-22 | Not classified | Other | Product packaging may contain holes compromising sterility. | 12,684 units (total includes both types) | 2004-09-01 |
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.