Cook
Ultrathane, Mac-Loc, Biliary Drainage Catheter Set with Neff Percutaneous Access Set
4manufacturers in China registered for this device type
19catalogue numbers in this listing
1510(k) clearance
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 | Cook Incorporated, United States |
|---|---|
| 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, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2020-11-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G05871 | In distribution | |
| G09326 | In distribution | |
| G06086 | In distribution | |
| G10047 | In distribution | |
| G11253 | In distribution | |
| G28914 | In distribution | |
| G08336 | In distribution | |
| G06713 | In distribution | |
| G05873 | In distribution | |
| G05870 | In distribution | |
| G10048 | In distribution | |
| G08335 | In distribution | |
| G06085 | In distribution | |
| G06083 | In distribution | |
| G31445 | In distribution | |
| G06084 | In distribution | |
| G28902 | In distribution | |
| G08249 | In distribution | |
| G07318 | 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 |
| 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 |
| Taxi | Lake Region Medical Limited | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173414 | 2018-06-22 |
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.