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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Comfortear™ - 10810003223583

Comfortear™ Punctum Plugs are packaged sterile and pre-loaded individually on the ergonomically designed Comfortear™ Insertion Tool in an impact-minimizing tray. Packaged two (2) individual sterile trays per box, the Comfortear™ individual sterile trays reduce the potential for unnecessary waste when only a single occulder is required. Pedi, 0.5mm.
MICROSPECIALITIES, INC.
24-2004
In Commercial Distribution

  • 30810003223587 ()
  • 10810003223583 ()

  • Outer Diameter: 0.5 Millimeter
24-2004

  • Lacrimal punctum plug

Comfortear™ - 10810003223576

Comfortear™ Punctum Plugs are packaged sterile and pre-loaded individually on the ergonomically designed Comfortear™ Insertion Tool in an impact-minimizing tray. Packaged two (2) individual sterile trays per box, the Comfortear™ individual sterile trays reduce the potential for unnecessary waste when only a single occulder is required. X-Small, 0.6mm.
MICROSPECIALITIES, INC.
24-2005
In Commercial Distribution

  • 30810003223570 ()
  • 10810003223576 ()

  • Outer Diameter: 0.6 Millimeter
24-2005

  • Lacrimal punctum plug

Comfortear™ - 10810003223569

Comfortear™ Punctum Plugs are packaged sterile and pre-loaded individually on the ergonomically designed Comfortear™ Insertion Tool in an impact-minimizing tray. Packaged two (2) individual sterile trays per box, the Comfortear™ individual sterile trays reduce the potential for unnecessary waste when only a single occulder is required. Small, 0.7mm.
MICROSPECIALITIES, INC.
24-2006
In Commercial Distribution

  • 30810003223563 ()
  • 10810003223569 ()

  • Outer Diameter: 0.7 Millimeter
24-2006

  • Lacrimal punctum plug

Comfortear™ - 10810003223552

Comfortear™ Punctum Plugs are packaged sterile and pre-loaded individually on the ergonomically designed Comfortear™ Insertion Tool in an impact-minimizing tray. Packaged two (2) individual sterile trays per box, the Comfortear™ individual sterile trays reduce the potential for unnecessary waste when only a single occulder is required. Medium, 0.8mm.
MICROSPECIALITIES, INC.
24-2007
In Commercial Distribution

  • 30810003223556 ()
  • 10810003223552 ()

  • Outer Diameter: 0.8 Millimeter
24-2007

  • Lacrimal punctum plug

Comfortear™ - 10810003223545

Comfortear™ Punctum Plugs are packaged sterile and pre-loaded individually on the ergonomically designed Comfortear™ Insertion Tool in an impact-minimizing tray. Packaged two (2) individual sterile trays per box, the Comfortear™ individual sterile trays reduce the potential for unnecessary waste when only a single occulder is required. Large, 0.9 mm.
MICROSPECIALITIES, INC.
24-2008
In Commercial Distribution

  • 30810003223549 ()
  • 10810003223545 ()

  • Outer Diameter: 0.9 Millimeter
24-2008

  • Lacrimal punctum plug

StatGuard Hemostatic Dressing, Regular - 10815614020828

The StatGuard Hemostatic Dressing is composed of a non-woven gauze made of chitosan which is applied to an arterial or venous puncture or incision to promote post-procedure hemostasis and control of moderate to severe wound bleeding, exudates absorption, and coagulation. Model 3020-10 provides a 2 cm x 3.5 cm gauze, in an 8 cm x 10 cm adhesive dressing
Semler Technologies, Inc.
3020-20
In Commercial Distribution

  • 10815614020828 ()
  • 20815614020825 ()
  • 30815614020822 ()
480-3020-20

  • Chitosan haemostatic agent, professional, non-bioabsorbable

StatGuard Hemostatic Dressing, Small - 10815614020811

The StatGuard Hemostatic Dressing is composed of a non-woven gauze made of chitosan which is applied to an arterial or venous puncture or incision to promote post-procedure hemostasis and control of moderate to severe wound bleeding, exudates absorption, and coagulation. Model 3020-10 provides a 2 cm x 3.5 cm gauze, in a 4 cm x 6 cm adhesive dressing.
Semler Technologies, Inc.
3020-10
In Commercial Distribution

  • 10815614020811 ()
  • 20815614020818 ()
  • 30815614020815 ()
480-3020-10

  • Chitosan haemostatic agent, professional, non-bioabsorbable

Facet Screw - 07290019421245

The subjected screw is part of the zLOCK Lumbar Facet Fixation System. The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components: 1) a Facet Screw with a washer and 2) a Modular spacer. The system including a dedicated tool set.
ZYGOFIX LTD
1
In Commercial Distribution

  • 07290019421245 ()
ZFS-40SC-25TU

  • Spinal bone screw, non-bioabsorbable

Facet screw - 07290019421238

The subjected screw is part of the zLOCK Lumbar Facet Fixation System. The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components: 1) a Facet Screw with a washer and 2) a Modular spacer. The system including a dedicated tool set.
ZYGOFIX LTD
1
Not in Commercial Distribution

  • 07290019421238 ()
ZF-40FS-20TU

  • Spinal bone screw, non-bioabsorbable

zLOCK tools Trays #1+ #3 - 07290019421160

The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components: 1) a Facet Screw with a washer and 2) a Modular spacer. The system including a dedicated tool set, contained in dedicated trays that are marked with UDI.
ZYGOFIX LTD
1
In Commercial Distribution

  • 07290019421160 ()
ZFT-100

  • Spinal bone screw, non-bioabsorbable
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