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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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No Description
SKELETAL DYNAMICS L.L.C.
Humeral Fixation Set Tray B, Bottom Insert
In Commercial Distribution

  • 00841506132525 ()
HFS-INSRT-BBOT

  • Instrument tray, reusable
No Description
SKELETAL DYNAMICS L.L.C.
Humeral Fixation Set Tray B, Middle Insert
In Commercial Distribution

  • 00841506132518 ()
HFS-INSRT-BMID

  • Instrument tray, reusable
No Description
SKELETAL DYNAMICS L.L.C.
Humeral Fixation Set Tray B, Top Insert
In Commercial Distribution

  • 00841506132501 ()
HFS-INSRT-BTOP

  • Instrument tray, reusable
Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
SPHERO B/M ReplaceSelect ø4.3 h0,5 TIN
Not in Commercial Distribution

  • D821003RPS4305R0 ()
003RPS4305R

  • Dental implant suprastructure, permanent, preformed
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
MASTERKA ® 40 (DESIGNER B. FAYET, M.D.)
In Commercial Distribution

  • 03760087123661 ()

  • Length: 40 Millimeter
  • Outer Diameter: 0.90 Millimeter
S1.1610

  • 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
MASTERKA ® 35 (DESIGNER B. FAYET, M.D.)
In Commercial Distribution

  • 03760087123654 ()

  • Length: 35 Millimeter
  • Outer Diameter: 0.90 Millimeter
S1.1609

  • 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
MASTERKA ® 30 (DESIGNER B. FAYET, M.D.)
In Commercial Distribution

  • 03760087123647 ()

  • Length: 30 Millimeter
  • Outer Diameter: 0.90 Millimeter
S1.1608

  • 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
PVP MONO-CRAWFORD WIDE COLLARETTE B. FAYET, MD
In Commercial Distribution

  • 33760087120623 ()
  • 03760087120622 ()

  • Length: 320 Millimeter
  • Outer Diameter: 0.64 Millimeter
S1.1953u

  • 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
PVP MONO-CRAWFORD MEDIUM COLLARETTE B. FAYET, MD
In Commercial Distribution

  • 33760087120517 ()
  • 03760087120516 ()

  • Length: 320 Millimeter
  • Outer Diameter: 0.64 Millimeter
S1.1943u

  • Lacrimal tube
No Description
MORIA SA
LSK C & B MANUAL FIXATION RING 2
In Commercial Distribution

  • 03700483608300 ()
19309/2

  • Microkeratome
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