Cook
Common Bile Duct Exploration Set
1manufacturer
1catalogue number
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | NWT |
| Device type | Endoscopic Cholangiogram Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2021-05-27 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| 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 |
|---|---|---|
| G26908 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RX Cholangiogram Kit | Boston Scientific Corporation | 52 |
| Cardinal Health | Cardinal Health 200, LLC | 10 |
| ACS | American Contract Systems, Inc. | 3 |
| Taut | Teleflex Medical LLC | 1 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 1 |
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.