Advanta Slider GDS
Advanta graft, 7MMx80CM, TW, H, FLARED END, ADV, AFT, GDS
6manufacturers in China registered for this device type
26catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
| Huaian Wolfram Surgical Instruments | Huaian | Jiangsu | Manufacturer | 14 |
| Global Medical Production Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Atrium Medical Corporation, United States |
|---|---|
| FDA product code | DWS |
| Device type | Instruments, Surgical, Cardiovascular |
| Device class | Class 1 |
| Regulation | 21 CFR 870.4500 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Record published | 2015-09-24 |
| Record revised | 2026-06-29 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, serial number |
| Storage | Storage environment temperature 59 to 77 °F |
| Distribution end date | 2021-02-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 22025 | In distribution | |
| 25007 | Withdrawn | |
| 25017 | Withdrawn | |
| 25026 | Withdrawn | |
| 25048 | Withdrawn | |
| 25014 | Withdrawn | |
| 22287 | Withdrawn | |
| 25004 | Withdrawn | |
| 22288 | Withdrawn | |
| 25044 | Withdrawn | |
| 25002 | Withdrawn | |
| 25042 | Withdrawn | |
| 25005 | Withdrawn | |
| 25041 | Withdrawn | |
| 25036 | Withdrawn | |
| 25023 | Withdrawn | |
| 25047 | Withdrawn | |
| 25030 | Withdrawn | |
| 25021 | Withdrawn | |
| 25012 | Withdrawn | |
| 22286 | Withdrawn | |
| 25011 | Withdrawn | |
| 25006 | Withdrawn | |
| 22092 | Withdrawn | |
| 25013 | Withdrawn | |
| 22125 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Delacroix-Chevalier | Landanger | 1,819 |
| Landanger | Landanger | 1,213 |
| Ambler Surgical | Ambler Surgical, LLC | 1,013 |
| Pilling | Teleflex Medical LLC | 971 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 876 |
| V. Mueller | Steris Corporation | 716 |
| Novo Surgical | Novo Surgical, Inc. | 387 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 364 |
| Instruments, Surgical, Cardiovascular | Fehling Instruments GmbH | 352 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 290 |
| Avalign | Avalign Technologies, Inc. | 283 |
| Millennium | Avalign Technologies, Inc. | 272 |
Showing 12 of 472. All products under Instruments, Surgical, Cardiovascular
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Atrium Medical Corporation | UDI-DI | 2024-05-03 | Class II | Equipment maintenance | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | 53,308 units (US: 11, 236; OUS: 42,072) |
| Atrium Medical Corporation | UDI-DI | 2024-05-03 | Class II | Equipment maintenance | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | 53,308 units (US: 11, 236; OUS: 42,072) |
| Atrium Medical Corporation | UDI-DI | 2024-05-03 | Class II | Equipment maintenance | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | 53,308 units (US: 11, 236; OUS: 42,072) |
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.