Hainwise Medical Technology Co., Ltd.
- E-mail: info@hainwise.com
Hainwise Medical Technology Co., Ltd.
Our single‑use angiographic guidewires (available from 450 mm up to 3500 mm) are engineered for reliable catheter delivery in diagnostic and interventional procedures. Designed for excellent trackability, controlled torque, and atraumatic navigation, these wires serve OEMs, hospitals and global distributors seeking customizable, regulatory‑grade consumables.
Full length range: Off‑the‑shelf options from 450 mm to 3500 mm to support short diagnostic access and long exchange procedures.
Material & performance: Available with stainless steel or nitinol cores; hydrophilic and PTFE/PTFE‑like coatings for low friction and superior device tracking. Core‑to‑tip designs preserve torque transmission and kink resistance.
Multiple diameters & tip options: Common diameters (e.g., 0.014", 0.018", 0.025", 0.035", 0.038") and tip styles (J, straight, floppy, angled, exchange) to match catheter lumen and procedural needs.
Single‑use sterile packaging: Supplied sterile; single‑use design avoids reuse/resterilization issues and supports infection control protocols.
OEM & custom solutions: Private‑labeling, custom lengths, tip geometry, radiopaque markers and bulk packaging available for distributors and OEM partners.
| Item | Options / Range |
|---|---|
| Length | 450 mm, 600 mm, 800 mm, 1000 mm, 1200 mm, 1500 mm, 2000 mm, 2500 mm, 3000 mm, 3500 mm (custom lengths available) |
| Diameter | 0.014" / 0.018" / 0.025" / 0.035" / 0.038" (other gauges on request) |
| Core material | Nitinol (kink‑resistant) or stainless steel (high pushability) |
| Coating | Hydrophilic coating, PTFE/PTFE‑like, or uncoated distal tip options |
| Tip styles | J‑tip, floppy, straight, angled, exchange, Baby‑J etc. |
| Radiopacity | Tungsten/platinum marker options for clear X‑ray visualization |
| Sterility | EO sterilized, single‑use, packaged sterile |
| Regulatory / QMS | Manufactured under ISO 13485, CE marking and can be produced in FDA‑registered facilities (where required) |
| MOQ / Packaging | Boxes of 5 / 10 / 25 — bulk and custom packing available for distributors |
Wire length selection depends on access site, catheter length and intended exchanges — as a rule of thumb, choose a wire length at least double the catheter length to allow safe exchanges and device movement during procedures. Common clinical guidewire lengths vary by procedure (many diagnostic/interventional wires fall between 145–260 cm), so longer (up to 3500 mm) options are used for special exchange/interventional workflows.
Single‑use labeling & warnings: Single‑use devices must not be reprocessed or resterilized — reusing single‑use guidewires is contraindicated and may compromise patient safety. Product labeling and IFU include single‑use warnings.
Standards & traceability: We operate under a documented QMS (ISO 13485) with lot traceability, incoming material checks, and full production records to support regulatory submissions and hospital procurement requirements.
Standard packaging: Individually sterile‑sealed pouches; labeled with lot, expiration, length, diameter and sterilization method.
Customization & private label: MOQ, lead time and artwork options available — typical OEM cycles depend on order size and regulatory documentation.
Logistics: Export packing per Incoterm (FOB/CIF/DDP options), compliance documentation (CO, CE‑Declaration, ISO certificates) supplied with bulk shipments.
Q: Are these guidewires reusable?
A: No — these items are designed and labeled for single use only. Do not reuse, reprocess, or resterilize.
Q: What lengths are most commonly stocked?
A: Common stocking lengths include 1000 mm, 1500 mm and 2000 mm for exchange procedures; we also keep fast‑moving diagnostic lengths (450–800 mm) and can produce up to 3500 mm on demand.
Q: Which coatings do you offer?
A: Hydrophilic (for lowest friction), PTFE/PTFE‑like (for tactile feedback), or uncoated tip variants; coatings and distal tip finish are customizable per OEM spec.
Q: What regulatory support do you provide for OEM customers?
A: We provide technical files, material certificates, sterilization validation summaries, and support for CE/ISO documentation; factory audits available for large partners.
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