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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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A sterile, implantable, single-lumen tube intended to provide tear drainage from the front surface of the eye, typically into the nasal cavity or a paranasal sinus, as a drainage treatment for lacrimal canalicular pathologies in functional or obstructive epiphora; it may also be intended to facilitate saline solution irrigation to a paranasal sinus (e.g., ethmoid sinus) to manage chronic rhinosinusitis. Also referred to as a lacrimal stent, the device may be implanted after surgery to dilate or create a surgical passage [e.g., dacryocystostomy/dacryocystorhinostomy (DCR)], and is made of glass or synthetic polymer material(s) [e.g., silicone].
FCI S A S FCI 20 22
RITLENG BICANALICULUS INTUBATION
In Commercial Distribution

  • 33760087120371 ()
  • 03760087120370 ()

  • Length: 300 Millimeter
  • Outer Diameter: 0.64 Millimeter
S1.1450u

  • Lacrimal tube
A sterile device inserted into a lacrimal punctum opening to prevent tear outflow in dry eye patients. This is a single-use device.
FCI S A S FCI 20 22
READY-SET PUNCTUM PLUG (MINI, US 0.7)
In Commercial Distribution

  • 23760087120060 ()
  • 03760087120066 ()

  • Outer Diameter: 0.55 Millimeter
S2.3672u

  • Lacrimal punctum plug
PAD, ALCOHOL PREP, STERILE, MEDIUM, NON-WOVEN, SIZE 30X60MM, 200EA/BX, 20BX/CS (4000EA/CS)
Asp Global, LLC
PPA020
In Commercial Distribution

  • 00840216108639 ()


  • Skin-cleaning wipe, sterile
PAD, ALCOHOL PREP, STERILE, LARGE
Asp Global, LLC
PPA030
Not in Commercial Distribution

  • 00840216108271 ()


  • Skin-cleaning wipe, sterile
Universal Reamer Holder for Foramatron® All Models
PARKELL, INC.
D619RH
Not in Commercial Distribution

  • M595D619RH0 ()
D619RH

  • Endodontic apex locator
Universal Ground Clip (Pkg. of 2 pcs.)
PARKELL, INC.
D619GC
Not in Commercial Distribution

  • M595D619GC1 ()
  • M595D619GC0 ()
D619GC

  • Endodontic apex locator
Quick Probe for Foramatron® All Models
PARKELL, INC.
D613
Not in Commercial Distribution

  • M595D6130 ()
D613

  • Endodontic apex locator
Touch-Proof Wire Assembly for Model D-10 Foramatron® (Includes: Lip Clips, Quick Test Probe Reamer Holder & Touch-Proof Wire)
PARKELL, INC.
D611
Not in Commercial Distribution

  • M595D6110 ()
D611

  • Endodontic apex locator
Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 60mm
NEXXT SPINE, LLC
14-12-5060
In Commercial Distribution

  • 00889929001400 ()

  • Length: 60 Millimeter
  • Outer Diameter: 5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 55mm
NEXXT SPINE, LLC
14-12-5055
In Commercial Distribution

  • 00889929001394 ()

  • Length: 55 Millimeter
  • Outer Diameter: 5 Millimeter


  • Spinal bone screw, non-bioabsorbable
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