ZIPwire™
Urological guidewire
2manufacturers in China registered for this device type
48catalogue 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 | Lake Region Medical Limited, Ireland |
|---|---|
| FDA product code | EYA |
| Device type | Stylet, Ureteral |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-10-31 |
| 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 |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in a cool, dry place. |
| Packaging | Pack of 5 |
| Sizes | Length 150 to 260 cm; guidewire diameter 0.018 to 0.038 in; guidewire length 150 to 260 cm; outer diameter 0.018 to 0.038 in; outer diameter 0.025 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M006630223B0 | Outer Diameter.035 in | In distribution |
| M0066802270 | Guidewire Diameter 0.038 in | In distribution |
| M006630210B0 | Outer Diameter.038 in | In distribution |
| M006630203B0 | Outer Diameter.035 in | In distribution |
| M006630224B0 | Outer Diameter.035 in | In distribution |
| M0066802070 | Guidewire Diameter 0.038 in | In distribution |
| M006630215B0 | Outer Diameter.038 in | In distribution |
| M0066802150 | Guidewire Diameter 0.038 in | In distribution |
| M0066802020 | Guidewire Diameter 0.025 in | In distribution |
| M006630225B0 | Outer Diameter.038 in | In distribution |
| M0066802160 | Guidewire Diameter 0.025 in | In distribution |
| M006630214B0 | Outer Diameter.035 in | In distribution |
| M006630227B0 | Outer Diameter.038 in | In distribution |
| M006630212B0 | Outer Diameter.032 in | In distribution |
| M0066802010 | Guidewire Diameter 0.025 in | In distribution |
| M006630207B0 | Outer Diameter.038 in | In distribution |
| M0066802000 | Guidewire Diameter 0.018 in | In distribution |
| M006630209B0 | Outer Diameter.038 in | In distribution |
| M006630200B0 | Outer Diameter.018 in | In distribution |
| M006630226B0 | Outer Diameter.038 in | In distribution |
| M0066802140 | Guidewire Diameter 0.035 in | In distribution |
| M0066802170 | Guidewire Diameter 0.025 in | In distribution |
| M006630206B0 | Outer Diameter.035 in | In distribution |
| M006630202B0 | Outer Diameter.025 cm | In distribution |
| M006630217B0 | Outer Diameter.025 in | In distribution |
| M006630216B0 | Outer Diameter.025 in | In distribution |
| M0066802120 | Guidewire Diameter 0.032 in | In distribution |
| M0066802280 | Guidewire Diameter 0.038 in | In distribution |
| M006630222B0 | Outer Diameter.035 in | In distribution |
| M0066802130 | Guidewire Diameter 0.032 in | In distribution |
| M006630221B0 | Outer Diameter.035 in | In distribution |
| M0066802030 | Guidewire Diameter 0.035 in | In distribution |
| M0066802100 | Guidewire Diameter 0.038 in | In distribution |
| M006630205B0 | Outer Diameter.035 in | In distribution |
| M0066802060 | Guidewire Diameter 0.035 in | In distribution |
| M006630228B0 | Outer Diameter.038 in | In distribution |
| M0066802080 | Guidewire Diameter 0.038 in | In distribution |
| M0066802260 | Guidewire Diameter 0.038 in | In distribution |
| M006630208B0 | Outer Diameter.038 in | In distribution |
| M0066802250 | Guidewire Diameter 0.038 in | In distribution |
| M0066802240 | Guidewire Diameter 0.035 in | In distribution |
| M006630201B0 | Outer Diameter.025 in | In distribution |
| M0066802050 | Guidewire Diameter 0.035 in | In distribution |
| M0066802210 | Guidewire Diameter 0.035 in | In distribution |
| M0066802230 | Guidewire Diameter 0.035 in | In distribution |
| M0066802220 | Guidewire Diameter 0.035 in | In distribution |
| M006630213B0 | Outer Diameter.032 in | In distribution |
| M0066802090 | Guidewire Diameter 0.038 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.