Core Dynamics
Laser Fiber Adapter for Delivery of a Laser Fiber through a Core Trumpet Hand Control, Reusable
1manufacturer
9catalogue numbers in this listing
6recalls on this code
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 | ConMed Corporation, United States |
|---|---|
| FDA product code | GBW |
| Device type | Catheter, Peritoneal |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2024-08-05 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 50 to 90 °F; Storage environment temperature 10 to 32 °C |
| Packaging | Box of 10, box of 20 |
| Distribution end date | 2026-03-24 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| CD8302 | 10 | In distribution | |
| CD8190 | 10 | In distribution | |
| CD8400 | 20 | In distribution | |
| CD8450 | 20 | In distribution | |
| CD8185 | 10 | In distribution | |
| CD8300 | 10 | In distribution | |
| CD850 | Electrode Probes | Withdrawn | |
| CD8200 | 10 | Withdrawn | |
| CD852 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jackson-Pratt | Cardinal Health 200, LLC | 28 |
| Cook | Cook Incorporated | 22 |
| Tenckhoff | Cook Incorporated | 13 |
| Taut | Teleflex Medical LLC | 13 |
| 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
Recalls
6 of these are 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 | Closed |
|---|---|---|---|---|
| 2016-06-27 | Class II | Under Investigation by firm | The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product. | 2018-06-07 |
| 2016-06-27 | Class II | Under Investigation by firm | The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product. | 2018-06-07 |
| 2016-06-27 | Class II | Under Investigation by firm | The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product. | 2018-06-07 |
| 2016-06-27 | Class II | Under Investigation by firm | The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product. | 2018-06-07 |
| 2016-06-27 | Class II | Under Investigation by firm | The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product. | 2018-06-07 |
| 2016-06-27 | Class II | Under Investigation by firm | The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product. | 2018-06-07 |
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.