ACS
Cholangiogram Pack (PS 71061)
1manufacturer
3catalogue 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 | American Contract Systems, Inc. |
|---|---|
| FDA product code | NWT |
| Device type | Endoscopic Cholangiogram Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Premarket notification | Exempt |
| Record published | 2023-09-27 |
| Record revised | 2022-06-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UICG81H | In distribution | |
| UICG81G | In distribution | |
| UICG81F | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RX Cholangiogram Kit | Boston Scientific Corporation | 52 |
| Cardinal Health | Cardinal Health 200, LLC | 10 |
| 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.