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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PSO OSTEOTOMES AND RETRACTORS INSERT
Avalign Technologies, Inc.
89000-02-01
In Commercial Distribution

  • 00190776161163 ()


  • Instrument tray, reusable
ORTHOFIX PSO AUXILIARY INSTRUMENT SET
Avalign Technologies, Inc.
42-2200
In Commercial Distribution

  • 00190776149406 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
ORTHOFIX PSO AUXILLARY SET CASE
Avalign Technologies, Inc.
42-2201
In Commercial Distribution

  • 00190776149284 ()


  • Instrument tray, reusable
ORTHOFIX PSO INSTRUMENT SET CASE
Avalign Technologies, Inc.
42-2101
In Commercial Distribution

  • 00190776149079 ()


  • Instrument tray, reusable
PSO Auxiliary Set Sterilization Case
SPINECRAFT, LLC
6500-200
In Commercial Distribution

  • 00193082113314 ()
6500-200

  • General internal orthopaedic fixation system implantation kit
PSO Core Set Sterilization Case
SPINECRAFT, LLC
6500-100-N
In Commercial Distribution

  • 00193082113130 ()
6500-100-N

  • General internal orthopaedic fixation system implantation kit
PSO Core Set Sterilization Case
SPINECRAFT, LLC
6500-100
In Commercial Distribution

  • 00193082113123 ()
6500-100

  • General internal orthopaedic fixation system implantation kit
MOSS PSO Compression Forceps with pawl
Biedermann Motech GmbH & Co. KG
208-020-0661
In Commercial Distribution

  • 04250869690973 ()
208-020-0661

  • General internal orthopaedic fixation system implantation kit
MOSS VRS PSO Valve adjustable, left
Biedermann Motech GmbH & Co. KG
208-010-0119
In Commercial Distribution

  • 04250869688567 ()
208-010-0119

  • General internal orthopaedic fixation system implantation kit
MOSS VRS PSO Valve adjustable, right
Biedermann Motech GmbH & Co. KG
208-010-0118
In Commercial Distribution

  • 04250869688550 ()
208-010-0118

  • General internal orthopaedic fixation system implantation kit
MOSS VRS PSO Pliers Blade left
Biedermann Motech GmbH & Co. KG
208-010-0116
In Commercial Distribution

  • 04250869688536 ()
208-010-0116

  • General internal orthopaedic fixation system implantation kit
MOSS VRS PSO Pliers Blade right
Biedermann Motech GmbH & Co. KG
208-010-0115
In Commercial Distribution

  • 04250869688529 ()
208-010-0115

  • General internal orthopaedic fixation system implantation kit
MOSS VRS PSO Pliers connector 150mm
Biedermann Motech GmbH & Co. KG
208-010-0114
In Commercial Distribution

  • 04250869688512 ()
208-010-0114

  • General internal orthopaedic fixation system implantation kit
MOSS VRS PSO Pliers Connector 75mm
Biedermann Motech GmbH & Co. KG
208-010-0111
In Commercial Distribution

  • 04250869688482 ()
208-010-0111

  • General internal orthopaedic fixation system implantation kit
MOSS VRS PSO Pliers Connector 50mm
Biedermann Motech GmbH & Co. KG
208-010-0110
In Commercial Distribution

  • 04250869688475 ()
208-010-0110

  • General internal orthopaedic fixation system implantation kit
Cervical PSO Chisel, 10mm, Right-Angle Straight
ALPHATEC SPINE, INC.
CI-11645-210
In Commercial Distribution

  • 00840180530894 ()


  • Orthopaedic osteotome
Cervical PSO Chisel, 8mm, Right-Angle Straight
ALPHATEC SPINE, INC.
CI-11645-208
In Commercial Distribution

  • 00840180530887 ()


  • Orthopaedic osteotome
Cervical PSO Chisel, 6mm, Right-Angle Straight
ALPHATEC SPINE, INC.
CI-11645-206
In Commercial Distribution

  • 00840180530870 ()


  • Orthopaedic osteotome
Flat Snap Housing Impression Transfer
BLUE SKY BIO LLC
FSI
In Commercial Distribution

  • 00810060221747 ()


  • Dental implant analog
RELINE 3CO Retractor Tips, PSO Short R
Nuvasive, Inc.
10000868
In Commercial Distribution

  • 00887517606693 ()


  • Internal spinal fixation procedure kit, reusable
RELINE 3CO Retractor Tips, PSO Short L
Nuvasive, Inc.
10000867
In Commercial Distribution

  • 00887517606686 ()


  • Internal spinal fixation procedure kit, reusable
Armada Ti 3CO Rack Tip, Right PSO
Nuvasive, Inc.
8992996
In Commercial Distribution

  • 00887517236586 ()


  • Internal spinal fixation procedure kit, reusable
Armada Ti 3CO Rack Tip, Left PSO
Nuvasive, Inc.
8992995
In Commercial Distribution

  • 00887517236579 ()


  • Internal spinal fixation procedure kit, reusable
Aqua-Fix Irrigating Syringe
HU-FRIEDY MFG. CO., LLC
IS
Not in Commercial Distribution

  • 10889950014186 ()
IS

  • Dental irrigation/aspiration syringe
IMPLANT SCREW
HI-TEC IMPLANTS LTD.
IS
In Commercial Distribution

  • 07290110722579 ()
IS

  • Dental implant suprastructure, temporary, preformed, single-use
POL GN BR 3-0 T-3 2N 30" PSO
TELEFLEX INCORPORATED
IPN026832
In Commercial Distribution

  • 34026704426271 ()
  • 14026704426277 ()
  • 04026704426270 ()

  • Length: 75 Centimeter
  • 'silky' II POLYDEK® /Needle T-3, T-3 Size-3-0
X-4192

  • Polyester suture, non-bioabsorbable, multifilament
POLYDEK GREEN BRAIDED 5-0 T-3 2N 30" PSO
TELEFLEX INCORPORATED
IPN028774
In Commercial Distribution

  • 34026704634058 ()
  • 14026704634054 ()
  • 04026704592869 ()

  • 'silky' II POLYDEK® /Needle T-3, T-3 Size-5-0
  • Length: 75 Centimeter
X-4195

  • Polyester suture, non-bioabsorbable, multifilament
POLYDEK GREEN BRAIDED 4-0 T-3 2N 30" PSO
TELEFLEX INCORPORATED
IPN028773
In Commercial Distribution

  • 34026704634041 ()
  • 14026704634047 ()
  • 04026704426287 ()

  • 'silky' II POLYDEK® /Needle T-3, T-3 Size-4-0
  • Length: 75 Centimeter
X-4194

  • Polyester suture, non-bioabsorbable, multifilament
MOSS VRS PSO Locking Cap for conncector DNI
Biedermann Motech GmbH & Co. KG
208-010-0121
In Commercial Distribution

  • 04250869697613 ()
208-010-0121

  • General internal orthopaedic fixation system implantation kit
MOSS VRS PSO Innie for conncector DNI, green
Biedermann Motech GmbH & Co. KG
208-010-0120
In Commercial Distribution

  • 04250869688574 ()
208-010-0120

  • General internal orthopaedic fixation system implantation kit
TEV GN BR 2-0 KAT-2 2N 30" PSO
TELEFLEX INCORPORATED
IPN026980
In Commercial Distribution

  • 44026704592980 ()
  • 24026704592986 ()
  • 04026704592982 ()

  • TEVDEK® II /Needle KAT-2, KAT-2 Size-2-0
  • Length: 75 Centimeter
X-5576

  • Polyester suture, non-bioabsorbable, multifilament
POL GN BR 3-0 AT-1 2N 30" PSO
TELEFLEX INCORPORATED
IPN026906
In Commercial Distribution

  • 24026704592924 ()
  • 04026704592920 ()
  • 44026704592928 ()

  • Length: 75 Centimeter
  • 'silky' II POLYDEK® /Needle AT-1, AT-1 Size-3-0
X-4672

  • Polyester suture, non-bioabsorbable, multifilament
POL GN BR 5-0 T-3 2N 30" PSO
TELEFLEX INCORPORATED
IPN026834
In Commercial Distribution

  • 44026704592867 ()
  • 24026704592863 ()
  • 04026704592869 ()

  • Length: 75 Centimeter
  • 'silky' II POLYDEK® /Needle T-3, T-3 Size-5-0
X-4195

  • Polyester suture, non-bioabsorbable, multifilament
POL GN BR 4-0 T-3 2N 30" PSO
TELEFLEX INCORPORATED
IPN026833
In Commercial Distribution

  • 44026704426285 ()
  • 24026704426281 ()
  • 04026704426287 ()

  • Length: 75 Centimeter
  • 'silky' II POLYDEK® /Needle T-3, T-3 Size-4-0
X-4194

  • Polyester suture, non-bioabsorbable, multifilament
POL GN BR 3-0 T-3 2N 30" PSO
TELEFLEX INCORPORATED
IPN026832
In Commercial Distribution

  • 24026704426274 ()
  • 04026704426270 ()
  • 44026704426278 ()

  • 'silky' II POLYDEK® /Needle T-3, T-3 Size-3-0
  • Length: 75 Centimeter
X-4192

  • Polyester suture, non-bioabsorbable, multifilament
No Description
BIOMET SPINE LLC
732M0235
In Commercial Distribution

  • 00880304860094 ()

  • PSO Angular Template 35°
732M0235

  • Spinal implant trial
No Description
BIOMET SPINE LLC
732M0230
In Commercial Distribution

  • 00880304860087 ()

  • PSO Angular Template 30°
732M0230

  • Spinal implant trial
No Description
BIOMET SPINE LLC
732M0225
In Commercial Distribution

  • 00880304860070 ()

  • PSO Angular Template 25°
732M0225

  • Spinal implant trial
Infant Regional Saturation Sensor Infant/Neonatal
Covidien LP
IS
In Commercial Distribution

  • 20884521810362 ()
  • 10884521810365 ()
  • 30884521810369 ()

  • Patient Weight, less than 40, kg only;


  • Cerebral oximeter sensor, single-use
OxyAlert NIRSensor Infant/Neonatal Sensor
Covidien LP
IS
In Commercial Distribution

  • 10884521211117 ()
  • 10884521552630 ()
  • 20884521211114 ()

  • Patient Weight, < 40, kg;


  • Cerebral oximeter sensor, single-use
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