Macintosh Fiber Optic Blade — Size #00 Neonatal

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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 420 / AISI 440 / 17-4 PH stainless steel · tungsten-carbide inserts where applicable
Sterilization: Steam autoclave to 134 °C · EtO compatible
Certifications: ISO 13485:2016 · CE-marked under EU MDR 2017/745 · FDA-registered
Shipping: DHL Express · UPS · FedEx · sea freight · all Incoterms

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

The Macintosh Fiber Optic Blade — Size #00 Neonatal (SKU DI 01-130-00) is part of the Fizza Surgical catalogue.

Reference / SKUDI 01-130-00
PatternMacintosh
MaterialAISI 303 / AISI 304 stainless steel (AISI 316 on fiber-optic variants)
SterilizationSteam autoclave to 134 °C · EtO compatible
Quality systemISO 13485:2016 · CE-marked (EU MDR 2017/745) · FDA-registered

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.

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 is the minimum order quantity for Fizza Surgical instruments?
Standard MOQ is 300 units per SKU for catalogue items, 500 units for fully custom designs. Sample orders of 10 units per SKU are available with the sample fee credited against the first production order.
Are Fizza Surgical instruments CE-marked and ISO 13485 certified?
Yes. All instruments are manufactured under an ISO 13485:2016 Quality Management System, CE-marked under EU MDR 2017/745, and our facility is FDA-registered. Specific certificate numbers and PDFs are on our Certifications page.
How long is the lead time and what shipping options are available?
18–22 working days for catalogue items, 28–35 days for custom designs. Shipping via DHL Express, UPS, FedEx, or sea freight on all standard Incoterms (EXW, FCA, FOB, CIF, DAP).
Can I order a custom OEM private-label run with my own branding?
Yes — private-label manufacturing from 300 units per SKU. Co-branded packaging, custom instrument-set design, and laser etching with your brand are all available.

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