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Northern Digital Inc devices, product family

by Northern Digital Inc 15 variants Basic UDI-DI 805832PASSIVEJ5

Shared by every variant

Manufacturer
Northern Digital Inc(15)
Basic UDI-DI
805832PASSIVEJ5
Risk class
Class IClass II (varies)
Legislation
MDDMDR (varies)
Market status
15 on the market
Official record
EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 805832PASSIVEJ5.

Recalls

20 recalls · 3 ongoing · FDA

  • Z-0194-2027 unclassified · ongoing · 31 Aug 2026
    Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.
  • Z-0196-2027 unclassified · ongoing · 31 Aug 2026
    Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.
  • Z-0195-2027 unclassified · ongoing · 31 Aug 2026
    Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.
  • Z-1600-2014 Class II · terminated · 24 Apr 2014
    Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
  • Z-1584-2014 Class II · terminated · 24 Apr 2014
    Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
  • Z-1601-2014 Class II · terminated · 24 Apr 2014
    Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
  • Z-1578-2014 Class II · terminated · 24 Apr 2014
    Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
  • Z-1580-2014 Class II · terminated · 24 Apr 2014
    Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
  • Z-1591-2014 Class II · terminated · 24 Apr 2014
    Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
  • Z-1590-2014 Class II · terminated · 24 Apr 2014
    Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
  • Z-1595-2014 Class II · terminated · 24 Apr 2014
    Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
  • Z-1594-2014 Class II · terminated · 24 Apr 2014
    Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
  • Z-1593-2014 Class II · terminated · 24 Apr 2014
    Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
  • Z-1596-2014 Class II · terminated · 24 Apr 2014
    Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
  • Z-1587-2014 Class II · terminated · 24 Apr 2014
    Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
  • Z-1592-2014 Class II · terminated · 24 Apr 2014
    Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
  • Z-1589-2014 Class II · terminated · 24 Apr 2014
    Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
  • Z-1585-2014 Class II · terminated · 24 Apr 2014
    Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
  • Z-1579-2014 Class II · terminated · 24 Apr 2014
    Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
  • Z-1602-2014 Class II · terminated · 24 Apr 2014
    Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.

Recalls matched to the 15 devices listed on this page; other pages of the family can carry others.

Variants

15 devices · page 1 of 1

Variants of Northern Digital Inc devices, Basic UDI-DI 805832PASSIVEJ5
UDI-DISize and differences
8800737 NDI Sterile Passive Spheres; 1 sphere per pouch; 5 pouches per box. Total 5 spheres per box 8800737D-88007372Z —On the market
8800738 NDI Sterile Passive Spheres; 3 spheres per pouch; 5 pouches per box. Total 15 spheres per box 8800738D-880073833 —On the market
8800739 NDI Sterile Passive Spheres; 4 spheres per pouch; 5 pouches per box. Total 20 spheres per box 8800739D-880073935 —On the market
8800965 NDI Sterile Passive Spheres; 9 spheres per tray; 2 trays per box. Total 18 spheres per box 8800965D-880096RW —On the market
8800966 NDI Sterile Passive Spheres; 15 spheres per tray; 2 trays per box. Total 30 spheres per box 8800966D-88009663J —On the market
8800967 NDI Sterile Passive Spheres; 12 spheres per tray; 2 trays per box. Total 24 spheres per box 8800967D-88009673L —On the market
8801002 NDI Sterile Passive Spheres; 5 spheres per tray; 12 trays per box. Total 60 spheres per 8801002D-8801002ZF —On the market
8801051 NDI Sterile Passive Spheres; 1 sphere per tray; 12 trays per box. Total 12 spheres per box 8801051D-8801051ZU —On the market
8801053 NDI Sterile Passive Spheres; 3 spheres per tray; 12 trays per box. Total 36 spheres per box 8801053D-880105323 —On the market
8801054 NDI Sterile Passive Spheres; 4 spheres per tray; 12 trays per box. Total 48 spheres per box 8801054D-880105425 —On the market
NDI Passive Spheres 8801320 8801320 / 880132000805832030047 —On the market
Passive Spheres™ 880107100805832070050 —On the market
Passive Spheres™ 880107400805832070067 —On the market
Passive Spheres™ 880107500805832070074 —On the market
Passive Spheres™ 880108500805832070081 —On the market