Dornier MedTech
Nitinol Hydrophilic Guide Wire 0.038", 150cm, Straight, 3cm tip, flexible one end, regular stiffness
2manufacturers in China registered for this device type
29catalogue numbers in this listing
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 | Dornier Medtech America, Inc., United States |
|---|---|
| FDA product code | EYA |
| Device type | Stylet, Ureteral |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-02-24 |
| Record revised | 2024-12-23 (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 |
| Packaging | Box of 5 |
| Distribution end date | 2018-12-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Angle, Flexible Tip, Stiff | In distribution | |
| Angle, Flexible Tip, Regular | In distribution | |
| Angle, Flexible Tip, Stiff | In distribution | |
| Straight, Flexible Tip, Stiff | In distribution | |
| APP3515S | In distribution | |
| PTFE Coated Guide Wire, Straight, Flexible Tip, Stiff | In distribution | |
| PTFE Coated Guide Wire, Angle, Flexible Tip, Stiff | In distribution | |
| Angle, Flexible Tip, Stiff | In distribution | |
| Straight, Flexible Tip, Regular | In distribution | |
| Dual Flex with Hydrophilic Tip, Straight, Stiff | In distribution | |
| Straight, Flexible Tip, Stiff | In distribution | |
| Dual Flex with Hydrophilic Tip, Angle, Stiff | In distribution | |
| Dual Flex with Hydrophilic Tip, Straight, Stiff | In distribution | |
| PTFE Coated Guide Wire, Straight, Flexible Tip, Stiff | In distribution | |
| Dual Flex with Hydrophilic Tip, Straight, Super Stiff | In distribution | |
| Straight, Flexible Tip, Regular | In distribution | |
| Dual Flex with Hydrophilic Tip, Straight, Super Stiff | In distribution | |
| Dual Flex with Hydrophilic Tip, Angle, Super Stiff | In distribution | |
| PTFE Coated Guide Wire, Angle, Flexible Tip, Stiff | In distribution | |
| Straight, Flexible Tip, Stiff | In distribution | |
| Straight, Flexible Tip, Regular | In distribution | |
| Angle, Flexible Tip, Regular | In distribution | |
| Dual Flex with Hydrophilic Tip, Angle, Super Stiff | In distribution | |
| MERI3815S | In distribution | |
| Angle, Flexible Tip, Regular | In distribution | |
| Dual Flex with Hydrophilic Tip, Angle, Stiff | In distribution | |
| PTFE Coated Guide Wire, Straight, Flexible Tip, Stiff | In distribution | |
| PTFE Coated Guide Wire, Angle, Flexible Tip, Stiff | In distribution | |
| SLID3515S | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ZIPwire™ | Lake Region Medical Limited | 48 |
| 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 |
| NaviBluTM Angled/Straight Dual Flexible:Nitinol Wire Hydrophilic Tips 0.035inch | Promepla | 1 |
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.