Taut
TAUT CHOLANGIOGRAPHY CATHETER 10/BOX 4.5 FRENCH x 30" NO METAL SUPPORT TUBE
1manufacturer
31catalogue 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 | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | GBZ |
| Device type | Catheter, Cholangiography |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-06-03 |
| Record revised | 2025-02-07 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10, box of 10 |
| Sizes | Length 18 in; width 1.5 to 2.5 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN029600 | In distribution | |
| IPN029599 | In distribution | |
| IPN925150 | In distribution | |
| IPN004147 | In distribution | |
| IPN925154 | Length 18 in | In distribution |
| IPN927861 | In distribution | |
| IPN004239 | Length 18 in | In distribution |
| IPN925149 | In distribution | |
| IPN010494 | In distribution | |
| IPN010493 | Length 18 in | In distribution |
| IPN925146 | In distribution | |
| IPN029598 | In distribution | |
| IPN927853 | In distribution | |
| IPN927860 | In distribution | |
| IPN029594 | Length 18 in | In distribution |
| IPN010495 | Width 2.2 mm | In distribution |
| IPN925153 | In distribution | |
| IPN029596 | Width 2.2 mm | In distribution |
| IPN925147 | In distribution | |
| IPN004241 | In distribution | |
| IPN927854 | In distribution | |
| IPN029595 | In distribution | |
| IPN004242 | In distribution | |
| IPN927856 | Width 2.5 mm | In distribution |
| IPN927855 | In distribution | |
| IPN004240 | In distribution | |
| IPN004142 | In distribution | |
| IPN925151 | In distribution | |
| IPN029597 | Length 18 in | In distribution |
| IPN029592 | In distribution | |
| IPN029593 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Olsen | Cook Incorporated | 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 |
|---|---|---|---|---|---|
| 2014-05-16 | Class II | Employee error | Several complaints were received for the metal support tube missing from the cholangiogram catheter. | 450 | 2015-11-04 |
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.