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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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Goblin Pedicle Screw System - 00810088653094

Open CC Str 150
Medynus, Inc
CRT-55150
In Commercial Distribution

  • 00810088653094 ()
CRT-55150

  • Bone-screw internal spinal fixation system, non-sterile

IdentiTi - 00190376364490

LIF INSERTER SLEEVE C-C
ALPHATEC SPINE, INC.
255-140-50
In Commercial Distribution

  • 00190376364490 ()


  • Metallic spinal interbody fusion cage

AMSure® Protective Cap - 10704411008422

AMSure® Protective Cap for 10 cc & 30 cc Syringes Radiation Resistant
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 10704411008422 ()
  • 40704411008423 ()
CAP1030

  • Radiation shielding head wear

Whitehall Thermalators - 00645724003939

THERMALATOR , 8 PACK, STATIONARY, -CC
Whitehall Manufacturing Co
ET-8-S-CC
In Commercial Distribution

  • 00645724003939 ()
ET8SCC

  • Cold therapy pack chilling unit
  • Hot therapy pack heating unit

Delara - J014660715010

Delara 6,C1/L33, CC
Kulzer GmbH
66071501
In Commercial Distribution

  • J014660715010 ()
66071501

  • Resin artificial teeth

ORTHOSOURCE - D9115574120

Red Etch 9 cc bottle
ORTHOSOURCE
557-412
In Commercial Distribution

  • D9115574120 ()


  • Dental etching solution

ORTHOSOURCE - D9115670410

Blue Etch 1.2 cc syringe
ORTHOSOURCE
567-041
In Commercial Distribution

  • D911557041503 ()
  • D9115670410 ()
  • D911567041202 ()
  • D91156704141 ()


  • Dental etching solution

ORTHOSOURCE - D9115670400

Red Etch 1.2 cc syringe
ORTHOSOURCE
567-040
In Commercial Distribution

  • D911557040503 ()
  • D9115670400 ()
  • D911567040202 ()
  • D91156704041 ()


  • Dental etching solution

CD HORIZON® Spinal System - 00613994590121

SCREW 54840009570 MAS 9.5X70 CC
MEDTRONIC SOFAMOR DANEK, INC.
54840009570
In Commercial Distribution

  • 00613994590121 ()

  • Length: 70.0 Millimeter
  • Outer Diameter: 9.75 Millimeter


  • Spinal bone screw, non-bioabsorbable

CD HORIZON® Spinal System - 00613994590107

SCREW 54840009580 MAS 9.5X80 CC
MEDTRONIC SOFAMOR DANEK, INC.
54840009580
In Commercial Distribution

  • 00613994590107 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 80.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
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