Cardinal Health
Sterile Choleangiogram Adds PK
1manufacturer
10catalogue 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 | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | NWT |
| Device type | Endoscopic Cholangiogram Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-07-19 |
| Record revised | 2022-06-10 (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 |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature up to 40 °C |
| Packaging | Case of 5, case of 8, case of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SAN57AAOHG | In distribution | |
| SOTCGCPPC1 | In distribution | |
| SAN57AAOHH | In distribution | |
| SAN57AAOHJ | In distribution | |
| SAN57AAOH1 | In distribution | |
| 33-8809A | In distribution | |
| SOTCGCPPC3 | In distribution | |
| SOTCGCPPC2 | In distribution | |
| SOTCGCPPCA | In distribution | |
| SAN57AAOHI | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RX Cholangiogram Kit | Boston Scientific Corporation | 52 |
| 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.