TH
TradeHub
Demonstration dataset. Supplier profiles, certificates and transaction history on this site are seeded sample data for product evaluation (seed v1.0.0). They are not verified real-world credentials and must not be used to make sourcing decisions.
THTradeHub
Request a quote

Surgical Instrument Handle, 17-4PH Stainless, ISO 13485 Process Control

Material: 17-4PH stainless (1.4542), H1025 conditionMOQ: 500 pcsLead time: 38 days

Precision-machined instrument handle in 17-4PH with passivation, cleanroom packing and lot genealogy from raw bar to finished part.

Document auditedManufacturerFDA Establishment Registration — expiringBusiness LicenseISO13485ISO9001Medical Device Components

Specification

Published as HTML so you can read it here, or in a search engine, without asking us first.
Technical specification for Surgical Instrument Handle, 17-4PH Stainless, ISO 13485 Process Control
PropertyValue
Material17-4PH stainless (1.4542), H1025 condition
HardnessHRC 32–36
Dimensional tolerance±0.01 mm on featured dimensions, CMM-verified
Surface roughnessRa ≤ 0.4 µm on grip surface
PassivationASTM F86, citric acid passivation
CleanlinessParticulate and bioburden tested per lot, ISO 11737-1
PackagingISO Class 8 cleanroom, double-bagged with lot label
Quality systemISO 13485:2016, process validation per IQ/OQ/PQ
TraceabilityFull lot genealogy from raw bar stock heat to packed component
How the price range is set

FOB Suzhou. Bioburden testing and cleanroom packing included. Sterilisation is excluded and remains the buyer’s process.

Request a quote for this part

The part, standard and supplier are already filled in. Two or three sentences about the application is enough for a firm answer.

Request a quote — Surgical Instrument Handle, 17-4PH Stainless, ISO 13485 Process Control

Enquiry about Surgical Instrument Handle, 17-4PH Stainless, ISO 13485 Process Control. For regulated components the paperwork is part of the product. If you are qualifying us as a second source, tell us which audit standard you will apply — we will send the validation documentation in advance rather than after you ask.

5 of 15 fields required (33%)
A named engineer replies within 24 hours (P95 under 4 hours)

A company address lets us route you to the right engineer. Personal addresses still get a reply.

Sets your currency, shipping terms and who answers you.

Pre-filled from the page you came from.

A range is enough — we do not need a firm number at this stage.

Two or three sentences about the application is more useful than a part number alone.

0 chars

Stating a range gets you a realistic answer instead of a padded one.

If your date is fixed we will say so honestly rather than accept an order we cannot hit.

Do you need a sample first?

Uploading a drawing at this stage removes the first email round-trip entirely.

I agree that TradeHub may process this enquiry and share it with the suppliers best able to fulfil it. I can withdraw at any time. *
Sarah Whitfield · English, German, Mandarin · 27 minutes median first reply
Prefer to talk first?
+44 20 7946 0958WhatsAppsourcing@tradehub.example

Answered 08:00–19:00 GMT, which covers EU business hours in full and US East Coast mornings. APAC enquiries received overnight are answered before 09:00 GMT.

Projects we have done on comparable parts

All case studies →
Medical devicesSurgical instrument OEM, United States

Passing a US OEM’s supplier audit on the first attempt for surgical instrument handles

Non-conformances raised during the buyer’s supplier audit
17 (previous candidate supplier)2
over a 210-day programme

A US surgical instrument OEM needed a second-source supplier that could pass a full on-site quality system audit rather than only present an ISO 13485 certificate, after its first alternative source failed the audit on process validation records.

Suzhou Meditech Components Co., Ltd.Read the evidence →
CallWhatsAppGet a quote