Manufacturer

Ndigital

CanadaLegal entities : Northern Digital Inc.

Markets : Germany · United States

Approvals : EU – class I · United States (FDA) – 510(k) : 1 · class II · latest in 2004 · see on the FDA website

EU representative : NDI Europe GmbH (Germany)

Website

1 category, 17 models including 17 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Stereotactic orthopaedic surgery instruments - consumables	Z12130485	41773 Disposable Reflective Marker Spheres; 3 spheres per tray; 30 trays per box. Total 90 spheres per box93/42 41813 Disposable Reflective Marker Spheres; 2 spheres per tray; 30 trays per box. Total 60 spheres per box93/42 8800737 NDI Sterile Passive Spheres; 1 sphere per pouch; 5 pouches per box. Total 5 spheres per box93/42 8800738 NDI Sterile Passive Spheres; 3 spheres per pouch; 5 pouches per box. Total 15 spheres per box93/42 8800739 NDI Sterile Passive Spheres; 4 spheres per pouch; 5 pouches per box. Total 20 spheres per box93/42 12 others 8800965 NDI Sterile Passive Spheres; 9 spheres per tray; 2 trays per box. Total 18 spheres per box93/42 8800966 NDI Sterile Passive Spheres; 15 spheres per tray; 2 trays per box. Total 30 spheres per box93/42 8800967 NDI Sterile Passive Spheres; 12 spheres per tray; 2 trays per box. Total 24 spheres per box93/42 8801002 NDI Sterile Passive Spheres; 5 spheres per tray; 12 trays per box. Total 60 spheres per93/42 8801051 NDI Sterile Passive Spheres; 1 sphere per tray; 12 trays per box. Total 12 spheres per box93/42 8801053 NDI Sterile Passive Spheres; 3 spheres per tray; 12 trays per box. Total 36 spheres per box93/42 8801054 NDI Sterile Passive Spheres; 4 spheres per tray; 12 trays per box. Total 48 spheres per box93/42 880107193/42 880107493/42 880107593/42 880108593/42 8801320 NDI Sterile Passive Spheres; 10 spheres per tray; 2 trays per box. Total 20 spheres per box93/42	I 93/42	EUDAMED record Report an error

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