RX Cholangiogram Kit
RX Cholangiogram Kit with Olympus Compatible Biopsy Cap
1manufacturer
52catalogue numbers in this listing
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 | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | NWT |
| Device type | Endoscopic Cholangiogram Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
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 |
| Packaging | Pack of 5, pack of 10, pack of 15, pack of 25, pack of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M00575230 | 450 cm Length | In distribution |
| M00575280 | 260 cm Length | In distribution |
| M00575440 | 260 cm Length | In distribution |
| M00571160 | 260 cm Length | In distribution |
| M00571400 | 260 cm Length | In distribution |
| M00575380 | 260 cm Length | In distribution |
| M00575080 | 260 cm Length | In distribution |
| M00571440 | 260 cm Length | In distribution |
| M00575360 | 260 cm Length | In distribution |
| M00575340 | 260 cm Length | In distribution |
| M00575210 | 450 cm Length | In distribution |
| M00575760 | 260 cm Length | In distribution |
| M00571520 | 260 cm Length | In distribution |
| M00571420 | 450 cm Length | In distribution |
| M00575260 | 260 cm Length | In distribution |
| M00575320 | 260 cm Length | In distribution |
| M00575040 | 260 cm Length | In distribution |
| M00575250 | 450 cm Length | In distribution |
| M00576080 | 260 cm Length | In distribution |
| M00575200 | 260 cm Length | In distribution |
| M00575240 | 260 cm Length | In distribution |
| M00575110 | 450 cm Length | In distribution |
| M00575850 | 450 cm Length | In distribution |
| M00571810 | 450 cm Length | In distribution |
| M00575970 | 450 cm Length | In distribution |
| M00571840 | 260 cm Length | In distribution |
| M00575480 | 260 cm Length | In distribution |
| M00576160 | 260 cm Length | In distribution |
| M00575960 | 260 cm Length | In distribution |
| M00571660 | 450 cm Length | In distribution |
| M00571480 | 260 cm Length | In distribution |
| M00571500 | 450 cm Length | In distribution |
| M00575690 | 450 cm Length | In distribution |
| M00571920 | 260 cm Length | In distribution |
| M00575600 | 260 cm Length | In distribution |
| M00571700 | 450 cm Length | In distribution |
| M00571720 | 260 cm Length | In distribution |
| M00575000 | 260 cm Length | In distribution |
| M00575330 | 450 cm Length | In distribution |
| M00571150 | 450 cm Length | In distribution |
| M00571560 | 260 cm Length | In distribution |
| M00575530 | 450 cm Length | In distribution |
| M00575400 | 260 cm Length | In distribution |
| M00575220 | 260 cm Length | In distribution |
| M00571180 | 450 cm Length | In distribution |
| M00571640 | 260 cm Length | In distribution |
| M00571800 | 260 cm Length | In distribution |
| M00575190 | 450 cm Length | In distribution |
| M00571040 | 260 cm Length | In distribution |
| M00575030 | 450 cm Length | In distribution |
| M00576000 | 260 cm Length | In distribution |
| M00571600 | 260 cm Length | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 10 |
| ACS | American Contract Systems, Inc. | 3 |
| Taut | Teleflex Medical LLC | 1 |
| Cook | Cook Incorporated | 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.