Taxi
7 catalogue numbers from SHTIF001, listed by Lake Region Medical Limited, Ireland, under Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (3), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Anrei Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 12 |
| Zhejiang Soudon Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 9 |
Record
| Listed by | Lake Region Medical Limited, Ireland |
|---|---|
| FDA product code | GCA |
| Device type | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5010 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2024-12-23 (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, manufacturing date |
| Storage | Special storage condition: The guidewire should be stored in an area with good ventilation at a controlled room temperature. Do not expose to extre |
| Sizes | Outer diameter 0.035 in; length 260 to 450 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SHTIF001 | Outer Diameter 0.035 in | In distribution |
| LR1BG056 | Outer Diameter 0.035 in | In distribution |
| LR1BG035 | Outer Diameter 0.035 in | In distribution |
| LR1IF001 | Outer Diameter 0.035 in | In distribution |
| LR1BG006 | Outer Diameter 0.035 in | In distribution |
| LR1BG034 | Outer Diameter 0.035 in | In distribution |
| LR1BG007 | Outer Diameter 0.035 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | Hangzhou AGS MedTech Co., Ltd. | 24 |
| Cook | Cook Incorporated | 19 |
| Tri-Ex | Cook Incorporated | 15 |
| Silicone T Drainage Tube | Fortune Medical Instrument Corp. | 10 |
| Silicone T Drainage Set With Eyes | Fortune Medical Instrument Corp. | 9 |
| Silicone T Drainage Tube With Eyes | Fortune Medical Instrument Corp. | 8 |
| Ring | Cook Incorporated | 8 |
| Silicone T Drainage Set | Fortune Medical Instrument Corp. | 7 |
| Fogarty | Edwards Lifesciences Technology Sarl | 6 |
| Silicone Y Drainage Tube | Fortune Medical Instrument Corp. | 6 |
| Duraglide | ConMed Corporation | 5 |
| Fusion Quattro | Cook Incorporated | 4 |
Showing 12 of 28. All products under Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
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.