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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COPILOT Kit includes Bleedback Control Valve 20/30 INDEFLATOR Inflation Device 30 atm 20 cc / Guide Wire Introducer / Torque Device
ABBOTT VASCULAR INC.
1003327
In Commercial Distribution

  • 08717648013973 ()
1003327

  • Catheter/overtube balloon inflator, single-use
HYDROGEL COATED LATEX FOLEY CATHETER, 5 CC, 3-WAY, 20 FR (6.7 MM)
Cardinal Health 200, LLC
2720
In Commercial Distribution

  • 20192253026242 ()
  • 10192253026245 ()
  • 50192253026243 ()
2720-

  • Indwelling urethral drainage balloon catheter, non-antimicrobial
HYDROGEL COATED LATEX FOLEY CATHETER, 30 CC, 2-WAY, 20 FR (6.7 MM)
Cardinal Health 200, LLC
1420
In Commercial Distribution

  • 20192253026068 ()
  • 10192253026061 ()
  • 50192253026069 ()
1420-

  • Indwelling urethral drainage balloon catheter, non-antimicrobial
3D Fusion™ Firm Matrix Band Special Kit: 80 Count (20) FXH100, (20) FXH175, (20) FXH200, (20) FXH300
GARRISON DENTAL SOLUTIONS, L.L.C.
FXHB03
In Commercial Distribution

  • 00810038095349 ()
FXHB03

  • Dental matrix band, single-use
A hand-held manual ophthalmic instrument designed to hold and insert an orbital sphere implant into the orbital cavity (eye socket). It typically has a body made of high-grade stainless steel with a piston used to forward the implant, which is held and positioned by the size-adjustable head of the device. This is a reusable device.
FCI S A S FCI 20 22
S6.3050
In Commercial Distribution

  • 13760087126386 ()


  • Orbital sphere implant introducer
A hand-held manual ophthalmic surgical instrument with small blades designed to grasp and manipulate ophthalmic implants (excluding sutures) during implantation/explantation; it is not intended for use on tissues. Its design may be tweezers-like, or it may be probe-like with a proximal handle, a thin cannula-like shaft, and small grasping blades that protrude from the distal end of the shaft. This is a reusable device intended to be sterilized prior to use.
FCI S A S FCI 20 22
S5.3100
In Commercial Distribution

  • 13760087126294 ()


  • Ophthalmic implant handling forceps, reusable
A slender hand-held manual instrument with a hook at its distal end designed to be inserted through the nose to extract a tube, cannula, or probe previously inserted into the lacrimal drainage system (the lacrimal duct), by pulling it out through the nose. This is a reusable device.
FCI S A S FCI 20 22
S1.1480
In Commercial Distribution

  • 13760087126256 ()


  • Transnasal lacrimal tube extractor
A hand-held manual ophthalmic surgical instrument with small blades designed to grasp and manipulate ophthalmic implants (excluding sutures) during implantation/explantation; it is not intended for use on tissues. Its design may be tweezers-like, or it may be probe-like with a proximal handle, a thin cannula-like shaft, and small grasping blades that protrude from the distal end of the shaft. This is a reusable device intended to be sterilized prior to use.
FCI S A S FCI 20 22
S1.1470
In Commercial Distribution

  • 13760087126249 ()


  • Ophthalmic implant handling forceps, reusable
A hand-held, manual, slender rod-like ophthalmic surgical instrument made of flexible metal, with a blunt bulbous tip, used for exploring the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a reusable device.
FCI S A S FCI 20 22
S1.1460
In Commercial Distribution

  • 13760087126232 ()


  • Ophthalmic surgical probe, reusable
No Description
FCI S A S FCI 20 22
S1.1275
In Commercial Distribution

  • 13760087126225 ()


  • Transnasal lacrimal tube extractor
No Description
FCI S A S FCI 20 22
A8.4050
In Commercial Distribution

  • 13760087126072 ()


  • Ophthalmic surgical probe, reusable
No Description
FCI S A S FCI 20 22
S1.4132
In Commercial Distribution

  • 13760087123842 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.
FCI S A S FCI 20 22
S1.4131
In Commercial Distribution

  • 13760087123835 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.
FCI S A S FCI 20 22
S1.4122
In Commercial Distribution

  • 13760087123828 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.
FCI S A S FCI 20 22
S1.4121
In Commercial Distribution

  • 13760087123811 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.
FCI S A S FCI 20 22
S1.4132
In Commercial Distribution



  • Ophthalmic surgical procedure kit, non-medicated, single-use
A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.
FCI S A S FCI 20 22
S1.4131
In Commercial Distribution



  • Ophthalmic surgical procedure kit, non-medicated, single-use
A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.
FCI S A S FCI 20 22
S1.4122
In Commercial Distribution



  • Ophthalmic surgical procedure kit, non-medicated, single-use
A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.
FCI S A S FCI 20 22
S1.4121
In Commercial Distribution

  • 13700773735096 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
Punctum plug
FCI S A S FCI 20 22
S2.3882
In Commercial Distribution

  • 23700773734805 ()
  • 13700773734808 ()


  • Lacrimal punctum plug
Punctum plugs
FCI S A S FCI 20 22
S2.3872
In Commercial Distribution

  • 23700773734799 ()
  • 13700773734792 ()


  • Lacrimal punctum plug
Punctum plug
FCI S A S FCI 20 22
S2.3862
In Commercial Distribution

  • 23700773734782 ()
  • 13700773734785 ()


  • Lacrimal punctum plug
Punctum plug
FCI S A S FCI 20 22
S2.3852
In Commercial Distribution

  • 23700773734775 ()
  • 13700773734778 ()


  • Lacrimal punctum plug
Punctum plug
FCI S A S FCI 20 22
S2.3842
In Commercial Distribution

  • 23700773734768 ()
  • 13700773734761 ()


  • Lacrimal punctum plug
Orbital implant
FCI S A S FCI 20 22
S6.6014
In Commercial Distribution

  • 13700773728890 ()


  • Orbital sphere implant
Orbital implant
FCI S A S FCI 20 22
S6.6012
In Commercial Distribution

  • 13700773728852 ()


  • Orbital sphere implant
Orbital implant
FCI S A S FCI 20 22
S6.6016
In Commercial Distribution

  • 13700773728081 ()


  • Orbital sphere implant
7 EXTERNAL EYELID WEIGHTS SIZING SET
FCI S A S FCI 20 22
S3.7000
In Commercial Distribution

  • 13700773727947 ()


  • Eyelid weight, external
EXTERNAL OCULID DARK BROWN® - 1,8 g
FCI S A S FCI 20 22
S3.60184
In Commercial Distribution

  • 13700773727930 ()


  • Eyelid weight, external
EXTERNAL OCULID MEDIUM BROWN® - 1,8 g
FCI S A S FCI 20 22
S3.60183
In Commercial Distribution

  • 13700773727923 ()


  • Eyelid weight, external
EXTERNAL OCULID TAN® - 1,8 g
FCI S A S FCI 20 22
S3.60182
In Commercial Distribution

  • 13700773727916 ()


  • Eyelid weight, external
EXTERNAL OCULID PINK® - 1,8 g
FCI S A S FCI 20 22
S3.60181
In Commercial Distribution

  • 13700773727909 ()


  • Eyelid weight, external
EXTERNAL OCULID LIGHT® - 1,8 g
FCI S A S FCI 20 22
S3.60180
In Commercial Distribution

  • 13700773727893 ()


  • Eyelid weight, external
EXTERNAL OCULID DARK BROWN® - 1,6 g
FCI S A S FCI 20 22
S3.60164
In Commercial Distribution

  • 13700773727886 ()


  • Eyelid weight, external
EXTERNAL OCULID MEDIUM BROWN® - 1,6 g
FCI S A S FCI 20 22
S3.60163
In Commercial Distribution

  • 13700773727879 ()


  • Eyelid weight, external
EXTERNAL OCULID TAN® - 1,6 g
FCI S A S FCI 20 22
S3.60162
In Commercial Distribution

  • 13700773727862 ()


  • Eyelid weight, external
EXTERNAL OCULID PINK® - 1,6 g
FCI S A S FCI 20 22
S3.60161
In Commercial Distribution

  • 13700773727855 ()


  • Eyelid weight, external
EXTERNAL OCULID LIGHT® - 1,6 g
FCI S A S FCI 20 22
S3.60160
In Commercial Distribution

  • 13700773727848 ()


  • Eyelid weight, external
EXTERNAL OCULID DARK BROWN® - 1,4 g
FCI S A S FCI 20 22
S3.60144
In Commercial Distribution

  • 13700773727831 ()


  • Eyelid weight, external
EXTERNAL OCULID MEDIUM BROWN® - 1,4 g
FCI S A S FCI 20 22
S3.60143
In Commercial Distribution

  • 13700773727824 ()


  • Eyelid weight, external
EXTERNAL OCULID TAN® - 1,4 g
FCI S A S FCI 20 22
S3.60142
In Commercial Distribution

  • 13700773727817 ()


  • Eyelid weight, external
EXTERNAL OCULID PINK® - 1,4 g
FCI S A S FCI 20 22
S3.60141
In Commercial Distribution

  • 13700773727800 ()


  • Eyelid weight, external
EXTERNAL OCULID LIGHT® - 1,4 g
FCI S A S FCI 20 22
S3.60140
In Commercial Distribution

  • 13700773727794 ()


  • Eyelid weight, external
EXTERNAL OCULID DARK BROWN® - 1,2 g
FCI S A S FCI 20 22
S3.60124
In Commercial Distribution

  • 13700773727787 ()


  • Eyelid weight, external
EXTERNAL OCULID MEDIUM BROWN® - 1,2 g
FCI S A S FCI 20 22
S3.60123
In Commercial Distribution

  • 13700773727770 ()


  • Eyelid weight, external
EXTERNAL OCULID TAN® - 1,2 g
FCI S A S FCI 20 22
S3.60122
In Commercial Distribution

  • 13700773727763 ()


  • Eyelid weight, external
EXTERNAL OCULID PINK® - 1,2 g
FCI S A S FCI 20 22
S3.60121
In Commercial Distribution

  • 13700773727756 ()


  • Eyelid weight, external
EXTERNAL OCULID LIGHT® - 1,2 g
FCI S A S FCI 20 22
S6.60120
In Commercial Distribution

  • 13700773727749 ()


  • Eyelid weight, external
EXTERNAL OCULID DARK BROWN® - 1,0 g
FCI S A S FCI 20 22
S3.60104
In Commercial Distribution

  • 13700773727732 ()


  • Eyelid weight, external
EXTERNAL OCULID MEDIUM BROWN® - 1,0 g
FCI S A S FCI 20 22
S3.60103
In Commercial Distribution

  • 13700773727725 ()


  • Eyelid weight, external
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