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
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-158
In Commercial Distribution

  • 09348215055875 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-024
In Commercial Distribution

  • 09348215055790 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
101-139
In Commercial Distribution

  • 09348215055356 ()


  • Orthopaedic broach
SMOKE EVACUATOR ARTICULATED, ARMSTAND WITH FASTENERS
BOVIE MEDICAL CORPORATION
SEAS
In Commercial Distribution

  • 10607151065161 ()
SEAS

  • Surgical plume evacuation system
Smoke Evacuation Tubing Support Stand
COASTAL LIFE TECHNOLOGIES, INC.
907001
In Commercial Distribution

  • 00814716020777 ()


  • Surgical plume evacuation system
Unit suction cover for the Aegis Air Filtration Unit - A Portable air filtration station to remove particulates and contaminants from the air within an enclosed room or space.
CAO GROUP, INC.
005-00089
In Commercial Distribution

  • 00872320005719 ()


  • Surgical plume evacuation system
Unit filtration cover for the Aegis Air Filtration Unit - A Portable air filtration station to remove particulates and contaminants from the air within an enclosed room or space.
CAO GROUP, INC.
005-00088
In Commercial Distribution

  • 00872320005702 ()


  • Surgical plume evacuation system
Portable air filtration station to remove particulates and contaminants from the air within an enclosed room or space.
CAO GROUP, INC.
005-00087
In Commercial Distribution

  • 00872320005696 ()


  • Surgical plume evacuation system
Replacement small square inlet collector for the Aegis Aerosol VacStation.
CAO GROUP, INC.
005-00086
In Commercial Distribution

  • 00872320005603 ()


  • Surgical plume evacuation system
Replacement primary cotton filter for the Aegis Aerosol VacStation.
CAO GROUP, INC.
005-00046
In Commercial Distribution

  • 00872320005450 ()
  • 00872320005504 ()


  • Surgical plume evacuation system
Replacement inlet collector for the Aegis Aerosol VacStation.
CAO GROUP, INC.
005-00050
In Commercial Distribution

  • 00872320005498 ()


  • Surgical plume evacuation system
Replacement collection tube for the Aegis Aerosol VacStation.
CAO GROUP, INC.
005-00049
In Commercial Distribution

  • 00872320005481 ()


  • Surgical plume evacuation system
Replacement charcoal filter cartridge for the Aegis Aerosol VacStation.
CAO GROUP, INC.
005-00048
In Commercial Distribution

  • 00872320005474 ()


  • Surgical plume evacuation system
Replacement secondary fiberglass filter for the Aegis Aerosol VacStation.
CAO GROUP, INC.
005-00047
In Commercial Distribution

  • 00872320005467 ()


  • Surgical plume evacuation system
Plume vacuum station to provide suction for removing plume, spray, and particulates generated during dental procedures.
CAO GROUP, INC.
005-00045
In Commercial Distribution

  • 00872320004958 ()


  • Surgical plume evacuation system
Adaptor For Valleylab Optimum
DEROYAL INDUSTRIES, INC.
88-000696
In Commercial Distribution

  • 50749756237494 ()
  • 00749756237499 ()
88-000696

  • Surgical plume evacuation system
Iris Scissors Curved Overall Length 4 1/4" (110mm) With Precision Two Tone Finish Country Of Origin Germany
Med Saver, Inc.
19-13106
In Commercial Distribution

  • 00194613069759 ()


  • Intraocular scissors, conventional-hinge, reusable
Iris Scissors Straight Overall Length 4 1/4" (110mm) With Precision Two Tone Finish Country Of Origin Germany
Med Saver, Inc.
19-13105
In Commercial Distribution

  • 00194613069711 ()


  • Intraocular scissors, conventional-hinge, reusable
Iris Scissors Curved Right Overall Length Of 4 1/2" (115mm) With Precision Two Tone Finish Country Of Origin Germany
Med Saver, Inc.
19-13112
In Commercial Distribution

  • 00194613069773 ()


  • Intraocular scissors, conventional-hinge, reusable
Spencer Stitch Scissor Straight With Notch Overall Length 3 1/2" (90mm) With Precision Two Tone Finish Country Of Origin Germany
Med Saver, Inc.
19-13280
In Commercial Distribution

  • 00194613024420 ()


  • Suture scissors
Strabismus Scissor Straight Overall Length 4 1/2" (115mm) Rounded Shanks And Round Tapper Blades With Precision Quality Two Tone Finish Country Of Origin Germany
Med Saver, Inc.
19-13137
In Commercial Distribution

  • 00194613069698 ()


  • Ophthalmic strabismus scissors, reusable
Strabismus Scissor Curved With Oval Shanks Overall Length 4 1/4" (110mm) Round Blunt End Blades With Precision Two Tone Finish Country Of Origin Germany
Med Saver, Inc.
19-13136
In Commercial Distribution

  • 00194613023379 ()


  • Intraocular scissors, conventional-hinge, reusable
Strabismus Scissor Straight With Oval Shanks Overall Length 4 1/4" (110mm) Round Blunt End Blades With Precision Two Tone Finish Country Of Origin Germany
Med Saver, Inc.
19-13135
In Commercial Distribution

  • 00194613023362 ()


  • Intraocular scissors, conventional-hinge, reusable
Mucicarmine demonstrates an affinity for mucins of epithelial origin. Aluminium is thought to form a chelation complex with carmine that binds with negatively charged acid mucins
RICHARD-ALLAN SCIENTIFIC COMPANY
Mucicarmine Stock Solution
In Commercial Distribution

  • 00673693089982 ()
88037

  • Biological stain IVD
Mucicarmine demonstrates an affinity for mucins of epithelial origin. Aluminium is thought to form a chelation complex with carmine that binds with negatively charged acid mucins
RICHARD-ALLAN SCIENTIFIC COMPANY
Chromaview™ - Advanced Testing Mucicarmine Stain
In Commercial Distribution

  • 00673693089227 ()
87012

  • Biological stain IVD
Iris Scissor Curved Square Edge Shanks Overall Length 4 1/2" (115mm) Sharp Pointed Tips Larger Ring Handles With Precision Two Tone Finish Country Of Origin Germany
Med Saver, Inc.
19-13109
In Commercial Distribution

  • 00194613069605 ()


  • Intraocular scissors, conventional-hinge, reusable
Iris Scissor Straight Square Edge Shanks Overall Length 4 1/2" (115mm) Sharp Pointed Tips Larger Ring Handles With Precision Two Tone Finish Country Of Origin Germany
Med Saver, Inc.
19-13108
In Commercial Distribution

  • 00194613069599 ()


  • Intraocular scissors, conventional-hinge, reusable
Iris Scissors Curved With Mid Screw To Tip Length Of 30mm, And An Overall Length Of 4 1/2" (115mm) With Precision Two Tone Finish Country Of Origin Germany
Med Saver, Inc.
19-13111
In Commercial Distribution

  • 00194613059057 ()


  • Intraocular scissors, conventional-hinge, reusable
Iris Scissors Straight With Mid Screw To Tip Length Of 30mm, And An Overall Length Of 4 1/2" (115mm) With Precision Two Tone Finish Country Of Origin Germany
Med Saver, Inc.
19-13110
In Commercial Distribution

  • 00194613059040 ()


  • Intraocular scissors, conventional-hinge, reusable
Iris Scissor Curved Square Edge Shanks Overall Length 3 3/4" (95mm) Sharp Pointed Tips Beveled Blades With Smaller Ring Handles With Precision Two Tone Finish Country Of Origin Germany
Med Saver, Inc.
19-13101
In Commercial Distribution

  • 00194613069551 ()


  • Intraocular scissors, conventional-hinge, reusable
Iris Scissor Straight Square Edge Shanks Overall Length 3 3/4" (95mm) Sharp Pointed Tips Beveled Blades With Smaller Ring Handles With Precision Two Tone Finish Country Of Origin Germany
Med Saver, Inc.
19-13100
In Commercial Distribution

  • 00194613069544 ()


  • Intraocular scissors, conventional-hinge, reusable
FREND™ Blocking Reagent is provided in 15 tubes, the blocking reagent is buffer based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The Blocking Reagent is provided in a dried solid state.
NanoEnTek, Inc.
FRBR 015
In Commercial Distribution

  • 08809317540825 ()
FRBR 015

  • Immunohistochemistry endogenous protein blocking reagent IVD
DR-HO's Perfect Back Rest This product is used for waist massage.Plastic injection molding into the ""S"" type, the external concave can better wrap the back of the human body, the middle part of the hemispherical origin, when the user by pressure, can be very good reaction force to the back, massage the effect.Products by the back, air cushion, fixed belt combination.
Guangzhou Xinbo Electronic Co., Ltd.
PBR-1
In Commercial Distribution

  • 06970742221473 ()


  • Back-filling orthosis
Rod Cutter. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-064
In Commercial Distribution

  • 00814008026128 ()


  • General internal orthopaedic fixation system implantation kit
Distractor, Titanium. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-059
In Commercial Distribution

  • 00814008026067 ()


  • General internal orthopaedic fixation system implantation kit
Compressor, Titanium. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-055
In Commercial Distribution

  • 00814008026050 ()


  • General internal orthopaedic fixation system implantation kit
Open Awl. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-027
In Commercial Distribution

  • 00814008025954 ()


  • General internal orthopaedic fixation system implantation kit
MIS Jamshidi. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-045
In Commercial Distribution

  • 00814008025756 ()


  • General internal orthopaedic fixation system implantation kit
MIS Persuader. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-009
In Commercial Distribution

  • 00814008025701 ()


  • General internal orthopaedic fixation system implantation kit
MIS Fulcrum. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-007
In Commercial Distribution

  • 00814008025695 ()


  • General internal orthopaedic fixation system implantation kit
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