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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 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
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
MINI MONOKA ® FAYET & BERNARD ®
In Commercial Distribution

  • 33760087120395 ()
  • 03760087120394 ()

  • Length: 50 Millimeter
S1.1500

  • Lacrimal tube
A sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a single-use device.
FCI S A S FCI 20 22
DISPOSABLE BICONCAVE LENS
In Commercial Distribution

  • 53760087122218 ()
  • 03760087122213 ()

  • Angle: 36 degree
S5.7040U

  • Vitrectomy contact lens, single-use
A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buckling for the surgical treatment of retinal detachment. It is typically a moulded solid silicone or silicone sponge device available in a variety of shapes and sizes that is used to compress the retina long-term (up to months) to support its reattachment following the operative treatment of severe retinal detachment. This device, also known as a scleral buckling component, will occupy the intraocular space to provide compression against the retina so that it can reattach. It is typically removed after a period of time depending upon the clinical findings.
FCI S A S FCI 20 22
BICONVEX TIRE 12 TYPE 289
In Commercial Distribution

  • 53760087121433 ()
  • 03760087121438 ()

  • Width: 10 Millimeter
  • Outer Diameter: 33.2 Millimeter
  • Lumen/Inner Diameter: 25.4 Millimeter
S5.2325U

  • Scleral buckling device, non-bioabsorbable
LEEP ELECTRODE 20 MM X 20 MM LOOP
ELMED INCORPORATED
5091
In Commercial Distribution

  • 00842180107267 ()
5091

  • Open-surgery electrosurgical electrode, monopolar, reusable
BLUNT BLADE, 20 x 20 MM, TEAL, PINNED
TEDAN SURGICAL INNOVATIONS, L.L.C.
CS-4028-P
In Commercial Distribution

  • 00843059122275 ()


  • Surgical retractor/retraction system blade, reusable
Evans Wedge Sizer Assy - 20 X 20, Reusable
IN2BONES USA, LLC
C01 N1021
In Commercial Distribution

  • 00810021866840 ()
C01 N1021

  • Orthopaedic implant aiming arm
Sterile drape sleeve for microTargeting Motor or Encoder
FHC, INC.
66-DA-SD-00436
In Commercial Distribution

  • 10873263004361 ()
  • 00873263004364 ()
66-DA-SD

  • Patient surgical drape, single-use
#20 Root Elevator
HU-FRIEDY MFG. CO., LLC
E20
In Commercial Distribution

  • 10889950009021 ()
E20

  • Dental elevator, tooth/root
20 Sicilia Periosteal
HU-FRIEDY MFG. CO., LLC
P20SIC6
In Commercial Distribution

  • 10889950017170 ()
P20SIC6

  • Periosteal elevator, reusable
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