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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
CRAWFORD BICANALICULUS INTUBATION
In Commercial Distribution

  • 33760087120234 ()
  • 03760087120233 ()

  • Length: 310 Millimeter
  • Outer Diameter: 0.64 Millimeter
S1.1270u

  • Lacrimal tube
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
INFANT BIKA BICANALICULUS INTUBATION J.A. BERNARD, M.D.
In Commercial Distribution

  • 33760087120173 ()
  • 03760087120172 ()

  • Length: 55 Millimeter
  • Outer Diameter: 0.64 Millimeter
S1.1100

  • Lacrimal tube
BIKA BICANALICULAR INTUBATION SET J.A. BERNARD, M.D.
FCI S A S FCI 20 22
S1.1000
In Commercial Distribution

  • 33760087120104 ()
  • 03760087120103 ()


  • 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
XEROSTOM® has been formulated to the relief of dry mouth symptoms such as difficulties in swallowing, speech, changes in taste, mouth discomfort, and other symptoms associated with dry mouth. These symptoms may be brought on by disease, stress, aging or medication. XEROSTOM® may be used to replace normal saliva, when salivary glands are damaged or not functioning. XEROSTOM® relieves the problems of dry mouth
BIO COSMETICS SL
Tube 25ml
In Commercial Distribution

  • 08426181972769 ()


  • Artificial saliva
BC SEALER SOLVENT 8OZ
Peter Brasseler Holdings, LLC
5031698U0
In Commercial Distribution

  • 08404535011982 ()


  • Root canal cleaning solution
Geenius SW V2.0 & APF V2.0 Installation Kit
Bio-RAD Laboratories, Inc.
12012851
In Commercial Distribution

  • 03610522168064 ()

  • 1 Each
12012851

  • HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay
Geenius Software V2.0 LIS Guide, US only
Bio-RAD Laboratories, Inc.
12012484
In Commercial Distribution

  • 03610522162260 ()

  • 1 Each
12012484

  • HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay
Geenius Blood Donor IFU & APF v2.0 binder
Bio-RAD Laboratories, Inc.
12012482
In Commercial Distribution

  • 03610522162239 ()

  • 1 each
12012482

  • HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay
Geenius HIV 1/2 Supplemental Assay 20t
Bio-RAD Laboratories, Inc.
72480
In Commercial Distribution

  • 03610521168942 ()

  • 20 Tests
72480

  • HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay
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