Olsen
Olsen Endoscopic Cholangiography Catheter Introducer
1manufacturer
7catalogue numbers in this listing
1recall
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 | GBZ |
| Device type | Catheter, Cholangiography |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-10-02 |
| Record revised | 2020-11-19 (version 2) |
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: Store in dark, dry, cool place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G05927 | In distribution | |
| G06167 | In distribution | |
| G08077 | In distribution | |
| G05926 | In distribution | |
| G06239 | In distribution | |
| G06168 | In distribution | |
| G06238 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Taut | Teleflex Medical LLC | 31 |
| PVC Thoracic Catheters | Atrium Medical Corporation | 30 |
| Cook | Cook Incorporated | 12 |
| Reddick Scoop Tip Cholangiogram Catheter | Lemaitre Vascular, Inc. | 8 |
| Symmetry Surgical | Aspen Surgical Products, Inc. | 8 |
| PMI | Progressive Medical Technology, Inc. | 8 |
| Reddick Cholangiogram Catheter | Lemaitre Vascular, Inc. | 7 |
| Princeton | Princeton Medical Group, Inc. | 3 |
| RX Ercp Cannula | Boston Scientific Corporation | 2 |
| Metal Catheter | RZ Medizintechnik Gmbh | 2 |
| Catheter, Cholangiography | Edwards Lifesciences Technology Sarl | 2 |
| Petelin | Cook Incorporated | 1 |
Showing 12 of 32. All products under Catheter, Cholangiography
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 |
|---|---|---|---|---|---|
| 2015-05-28 | Class II | Component change control | Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and the Flexor RTPS Introduce Sheath due to complaints of the dilators being too long. | 661 | 2017-05-30 |
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.