#00 Macintosh Fiber Optic Blade

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#00 Macintosh Fiber Optic Blade :

Its laryngoscope blade used to examine the larynx of premature babies. Its length is 65mm. Our new, innovative manufacturing technology achieves even better illumination and a longer service life.we can design your product with your Technical Drawing with Highest Quality Raw Material.

MOQ: 50 pieces
Lead time: 18–22 working days
Sample order: 10 units · sample fee credited against first PO
OEM private label: Private-label from 300 units per SKU
Materials: AISI 303 / AISI 304 stainless steel (AISI 316 on fiber-optic variants)
Sterilization: Steam autoclave to 134 °C · EtO compatible
Certifications: ISO 13485:2016 · CE-marked under EU MDR 2017/745 · FDA establishment-registered
Shipping: DHL Express · UPS · FedEx · sea freight · all Incoterms

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SKU DI 01-130-00 Categories , ,
Regulatory Nomenclature
EMDN (EUDAMED): V0303100201
GMDN Code: 35192
Laryngoscope blade, rigid, reusable

Catalogue reference DI 01-130-00 — #00 Macintosh Fiber Optic Blade, supplied to hospitals, distributors, and OEM partners.

The Macintosh laryngoscope blade — designed by Scottish anaesthetist Robert Reynolds Macintosh in 1943 at Oxford — is the most widely used laryngoscope blade worldwide. The curved profile fits the tongue’s anatomy: the blade tip sits in the vallecula (the space between tongue base and epiglottis), and lifting the handle indirectly raises the epiglottis to expose the glottis. This indirect technique reduces the risk of damaging the epiglottis compared with the older Miller (straight) blade approach. Macintosh blades are manufactured in sizes 0 (neonatal) through 4 (large adult); sizes 3 and 4 cover most adult intubations. Modern fiber-optic Macintoshes have largely replaced bulb variants in operating theatres.

Reference / SKU DI 01-130-00
Pattern Macintosh
Material AISI 303 / AISI 304 stainless steel (AISI 316 on fiber-optic variants)
Sterilization Steam autoclave to 134 °C · EtO compatible
Quality system ISO 13485:2016 · CE-marked (EU MDR 2017/745) · FDA-registered
Other Macintosh sizes in our catalogue:

Manufacturing compliance is verified through ISO 13485:2016 certification (the international medical-device quality standard), CE marking under EU MDR 2017/745, and FDA establishment registration. Certificate copies and regulatory documentation are available on request for inclusion in hospital procurement files and EU technical documentation packages. Sterilization validation follows ISO 17665 for steam autoclave at 134 °C.

What laryngoscope blade sizes and types do you manufacture?
Macintosh (curved) and Miller (straight) blades in sizes 0 (neonatal) through 4 (large adult), available in both conventional bulb and fiber-optic configurations. All blades are forged from AISI 420 stainless steel and autoclavable to 134 °C.
Are your laryngoscopes CE-marked?
Yes. All Fizza laryngoscope blades and handles are CE-marked Class I medical devices under EU MDR 2017/745, manufactured under ISO 13485:2016 QMS.
What is the MOQ for laryngoscope private-label production?
Standard MOQ is 50 sets for complete intubation kits (blades 0–4 with handle), or 300 units per blade size for individual blades.
Do you supply complete intubation sets?
Yes — complete intubation kits including handles (small and large), Macintosh or Miller blade sets sizes 0–4, and rigid storage cases are available. Co-branded packaging available from 100 sets.

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