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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
BIOMET SPINE LLC
4431-1018
In Commercial Distribution

  • 00887868166488 ()

  • Plate One Level Ti 18mm
4431-1018

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
4431-1034
In Commercial Distribution

  • 00888480519423 ()

  • PLATE ONE LEVEL TI 34MM
4431-1034

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
4431-1032
In Commercial Distribution

  • 00888480519416 ()

  • PLATE ONE LEVEL TI 32MM
4431-1032

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
4431-1030
In Commercial Distribution

  • 00888480519409 ()

  • PLATE ONE LEVEL TI 30MM
4431-1030

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
4431-1028
In Commercial Distribution

  • 00888480519393 ()

  • PLATE ONE LEVEL TI 28MM
4431-1028

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
4431-1026
In Commercial Distribution

  • 00888480519386 ()

  • PLATE ONE LEVEL TI 26MM
4431-1026

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
4431-1024
In Commercial Distribution

  • 00888480519379 ()

  • PLATE ONE LEVEL TI 24MM
4431-1024

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
4431-1022
In Commercial Distribution

  • 00888480519362 ()

  • PLATE ONE LEVEL TI 22MM
4431-1022

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
4431-1020
In Commercial Distribution

  • 00888480519355 ()

  • PLATE ONE LEVEL TI 20MM
4431-1020

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
4431-1018
In Commercial Distribution

  • 00888480519348 ()

  • PLATE ONE LEVEL TI 18MM
4431-1018

  • Bone-screw internal spinal fixation system, non-sterile
No Description
Zimmer, Inc.
1179-24
In Commercial Distribution

  • 00889024035164 ()

  • Length: 9 Inch
  • One 3.5 mm Screw Tine
00-1179-024-00

  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
BIOMET SPINE LLC
83112E
In Commercial Distribution

  • 00880304986732 ()

  • ONE LEVEL 12 MM PLATE
83112E

  • Bone-screw internal spinal fixation system, sterile
No Description
BIOMET SPINE LLC
83114E
In Commercial Distribution

  • 00880304986725 ()

  • ONE LEVEL 14 MM PLATE
83114E

  • Bone-screw internal spinal fixation system, sterile
No Description
BIOMET SPINE LLC
83116E
In Commercial Distribution

  • 00880304986718 ()

  • ONE LEVEL 16 MM PLATE
83116E

  • Bone-screw internal spinal fixation system, sterile
No Description
BIOMET SPINE LLC
83118E
In Commercial Distribution

  • 00880304986701 ()

  • ONE LEVEL 18 MM PLATE
83118E

  • Bone-screw internal spinal fixation system, sterile
No Description
BIOMET SPINE LLC
83120E
In Commercial Distribution

  • 00880304986695 ()

  • ONE LEVEL 20 MM PLATE
83120E

  • Bone-screw internal spinal fixation system, sterile
No Description
BIOMET SPINE LLC
83122E
In Commercial Distribution

  • 00880304986688 ()

  • ONE LEVEL 22 MM PLATE
83122E

  • Bone-screw internal spinal fixation system, sterile
No Description
BIOMET SPINE LLC
83124E
In Commercial Distribution

  • 00880304986671 ()

  • ONE LEVEL 24 MM PLATE
83124E

  • Bone-screw internal spinal fixation system, sterile
Root Canal Gel Tube
ESSENTIAL DENTAL SYSTEMS, INC.
1610-00
In Commercial Distribution

  • 00766054000150 ()

  • One - 7.5 gram Gel Tube
1610-00

  • Hygroscopic dental cement
Sensor Wraps;For use with OXI-A/N, OXI-P/I, D-YS.
Covidien LP
POSEY
In Commercial Distribution

  • 10884521144897 ()
  • 20884521521145 ()

  • Product Size, One Size, NA;


  • Transcutaneous blood gas monitor sensor
One transseptal dilator; one J-tip guidewire.
Baylis Médicale Cie Inc
ESD125-35-85-70-N
Not in Commercial Distribution

  • 00685447003038 ()

  • 12.5F 85cm Transseptal Dilator with Max OD = 4.17mm; 180cm J-Tip Guidewire with OD = 0.81mm and tip shape = 3mm J; Max Guidewire OD = 0.89mm.


  • Vascular guide-catheter, single-use
One transseptal dilator; one J-tip guidewire.
Baylis Médicale Cie Inc
ESD125-35-67-70-N
Not in Commercial Distribution

  • 00685447003021 ()

  • 12.5F 67cm Transseptal Dilator with Max OD = 4.17mm; 180cm J-Tip Guidewire with OD = 0.81mm and tip shape = 3mm J; Max Guidewire OD = 0.89mm.


  • Vascular guide-catheter, single-use
One transseptal dilator; one J-tip guidewire.
Baylis Médicale Cie Inc
ESD125-35-67-70-N
Not in Commercial Distribution

  • 00685447004691 ()

  • 12.5F 67cm Transseptal Dilator with Max OD = 4.17mm; 180cm J-Tip Guidewire with OD = 0.81mm and tip shape = 3mm J; Max Guidewire OD = 0.89mm.


  • Vascular guide-catheter, single-use
One transseptal dilator; one J-tip guidewire.
Baylis Médicale Cie Inc
ESD125-35-85-70-N
Not in Commercial Distribution

  • 00685447004707 ()

  • 12.5F 85cm Transseptal Dilator with Max OD = 4.17mm; 180cm J-Tip Guidewire with OD = 0.81mm and tip shape = 3mm J; Max Guidewire OD = 0.89mm.


  • Vascular guide-catheter, single-use
No Description
Hengshui Xukang Medical Appliances Co.,Ltd
One Size
In Commercial Distribution

  • 06974518523143 ()


  • General-purpose patient lifting system sling/harness
No Description
LUMENIS INC.
Vision One
Not in Commercial Distribution

  • 07290109143286 ()


  • General/multiple surgical frequency-doubled solid-state laser system
OWANDY ONE SIZE 2
OWANDY RADIOLOGY
ONE #2
In Commercial Distribution

  • 03760262651125 ()
9458600200

  • Dental digital imaging sensor, intraoral
OWANDY ONE SIZE 1
OWANDY RADIOLOGY
ONE #1
In Commercial Distribution

  • 03760262651118 ()
9458600100

  • Dental digital imaging sensor, intraoral
Disposable 1mL Luer Lock Syringe
AIR-TITE PRODUCTS COMPANY, INC.
MinimLL ONE
In Commercial Distribution

  • 20850017403721 ()
  • 10850017403724 ()
  • 00850017403727 ()
MINI1

  • General-purpose syringe, single-use
CO2 Fractional laser system
Jeisys Medical Inc.
Edge ONE
In Commercial Distribution

  • 8800020110039 ()
  • 08800020110015 ()


  • Dermatological carbon dioxide laser system
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