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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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Duckbill Targeting Awl
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GL116TA0 ()
GL116-TA

  • Bone awl, reusable
1/4" Connector Probe - Curved
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GL11380 ()
GL113-8

  • Bone awl, reusable
1/4" Connector Probe - Straight
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GL11370 ()
GL113-7

  • Bone awl, reusable
1/4" Connector Probe - Slim Duckbill
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GL11360 ()
GL113-6

  • Bone awl, reusable
1/4" Connector Probe - Duckbill
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GL11350 ()
GL113-5

  • Bone awl, reusable
1/4" Connector Probe - Curved Tapered Lenke
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GL11340 ()
GL113-4

  • Bone awl, reusable
1/4" Connector Probe - Tapered Lenke
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GL11330 ()
GL113-3

  • Bone awl, reusable
1/4" Connector Probe - Curved Lenke
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GL11320 ()
GL113-2

  • Bone awl, reusable
1/4" Connector Probe - Lenke
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GL11310 ()
GL113-1

  • Bone awl, reusable
NeuroBalloon™ NEUROBALLOON™ CATHETER
Integra LifeSciences Switzerland Sàrl
7CBD10
In Commercial Distribution

  • M2727CBD101 ()
  • 10381780035343 ()

  • Balloon waist diameter upon inflation: 3.5 mm minimum at 0.6 ml (0.6cc) of air, 6 mm maximum at 1 ml (1cc) of air; Cath. 60cm mini. Length; for insertion into a F4 minimum (1.35mm) diameter channel
7CBD10

  • Neural-tissue balloon catheter
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