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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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PolyLock - 00840124519626

2.7mm Locking Turret SB
FUSION ORTHOPEDICS, LLC
TN-SB-5027
In Commercial Distribution

  • 00840124519626 ()
TN-SB-5027

  • Bone screw fixation sleeve

PolyLock - 00840124519596

2.4mm LockingTurret SB
FUSION ORTHOPEDICS, LLC
TN-SB-5024
In Commercial Distribution

  • 00840124519596 ()
TN-SB-5024

  • Bone screw fixation sleeve

IntraLock - 00840124519213

Window 6mm LapiLock Tissue Protector
FUSION ORTHOPEDICS, LLC
TN-LL-5860
In Commercial Distribution

  • 00840124519213 ()
TN-LL-5860

  • Bone screw fixation sleeve

FuzeFix Chamfered Screws - 00840124518513

4.0mm Tissue Protector
FUSION ORTHOPEDICS, LLC
TN-CS-8040
In Commercial Distribution

  • 00840124518513 ()
TN-CS-8040

  • Bone screw fixation sleeve

FuzeFix Chamfered Screws - 00840124518490

3.0mm Tissue Protector
FUSION ORTHOPEDICS, LLC
TN-CS-8030
In Commercial Distribution

  • 00840124518490 ()
TN-CS-8030

  • Bone screw fixation sleeve

FuzeFix Chamfered Screws - 00840124518476

1.6mm K-Wire Protector
FUSION ORTHOPEDICS, LLC
TN-CS-8016
In Commercial Distribution

  • 00840124518476 ()
TN-CS-8016

  • Bone screw fixation sleeve

Drive - 00822383524535

Pressure PreventionGroup 1 Surfaces Product Description: Enf.,Dlx APP w/Pad w/End Flaps,1/ea, RTL
Drive Devilbiss Healthcare
E-14001EFD
In Commercial Distribution

  • 50822383524530 ()
  • 00822383524535 ()


  • Alternating-pressure bed mattress overlay system
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay, reusable

DRIVEMEDICAL - 00822383145457

Pressure PreventionGroup 1 Surfaces Product Description: Dlx APP w/Pad w/End Flaps,1/CV, 6/CT
Drive Devilbiss Healthcare
14001EFD
In Commercial Distribution

  • 00822383145457 ()
  • 50822383145452 ()


  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay system

Pro-fix™ Precision Fixation System - D765PFB140

1.5 mm x 14.0 mm self-tapping titanium alloy bone fixation screwhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Osteogenics Biomedical Inc
PFB14
In Commercial Distribution

  • D765PFB140 ()

  • Length: 14.0 Millimeter


  • Craniofacial bone screw, non-bioabsorbable

BD Pyxis™ - 10885403520341

BD Pyxis™ Enterprise Server ES (v5.7)
CAREFUSION 303, INC.
SW-SVR-ES-57
In Commercial Distribution

  • 10885403520341 ()


  • Anaesthesia cabinet
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