Cook
Spiral Chronic Peritoneal Dialysis Catheter Tray Silicone Catheter with 16 Fr Peel Away Introducer Set
1manufacturer
22catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | GBW |
| Device type | Catheter, Peritoneal |
| 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 | 2019-04-17 (version 4) |
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. |
| Distribution end date | 2022-02-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G05267 | In distribution | |
| G09273 | In distribution | |
| G04385 | In distribution | |
| G05268 | In distribution | |
| G09259 | In distribution | |
| G05264 | In distribution | |
| G05263 | In distribution | |
| G09269 | In distribution | |
| G29431 | In distribution | |
| G08997 | In distribution | |
| G09264 | In distribution | |
| G09271 | In distribution | |
| G09266 | In distribution | |
| G09265 | In distribution | |
| G09255 | In distribution | |
| G08983 | In distribution | |
| G09252 | In distribution | |
| G09251 | In distribution | |
| G02625 | In distribution | |
| G05262 | In distribution | |
| G09270 | In distribution | |
| G06373 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jackson-Pratt | Cardinal Health 200, LLC | 28 |
| Tenckhoff | Cook Incorporated | 13 |
| Taut | Teleflex Medical LLC | 13 |
| Core Dynamics | ConMed Corporation | 9 |
| Silicone Sump Drain Tube | Fortune Medical Instrument Corp. | 9 |
| Arrow | Teleflex Medical LLC | 8 |
| Merit Medical® | Merit Medical Systems, Inc. | 5 |
| Grafco | GF Health Products, Inc | 5 |
| Cardinal Health | Cardinal Health 200, LLC | 4 |
| Malecot | Boston Scientific Corporation | 3 |
| DeRoyal | Deroyal Industries, Inc. | 2 |
| Stenting Malecot | Boston Scientific Corporation | 2 |
Showing 12 of 15. All products under Catheter, Peritoneal
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.