Amplatz
Guidewire 0.035" (0.89 mm) x 150 cm Super Stiff Body, 9 cm Straight (5/PK)
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shandong (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| Innovex Medical Co., Ltd. | Shanghai | Shanghai | Manufacturer | 5 |
Record
| Listed by | Gyrus Acmi, Inc., United States |
|---|---|
| FDA product code | EYA |
| Device type | Stylet, Ureteral |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-09-11 |
| Record revised | 2024-12-23 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 13BX | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ZIPwire™ | Lake Region Medical Limited | 48 |
| Dornier MedTech | Dornier Medtech America, Inc. | 29 |
| HNM Medical | HNM Stainless, LLC. | 21 |
| SureGlide | Gyrus Acmi, Inc. | 11 |
| Olympus | Gyrus Acmi, Inc. | 6 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 6 |
| Hydrophilic Nitinol Guide Wire,.035x150cm, standard, 3cm flexible J tip | Promepla | 2 |
| Rio Tracer – Hydrophilic Dual Flexible.035x150cm | Promepla | 2 |
| Novo Surgical | Novo Surgical, Inc. | 2 |
| Rio Tracer – Hydrophilic Angled/Straight Dual Flexible.035x150cm | Promepla | 2 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 2 |
| Hydrophilic Nitinol Guidewire Ø 0.035”, L. 150cm, standard, with 3cm straight fl | Promepla | 2 |
Showing 12 of 42. All products under Stylet, Ureteral
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.