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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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MIS Fusion Plate with HA Coating
Spinal Simplicity, LLC
10-0005-012
In Commercial Distribution

  • M9431000050120 ()


  • Interspinous spinal fixation implant
MIS Fusion Plate with HA Coating
Spinal Simplicity, LLC
10-0005-010
In Commercial Distribution

  • M9431000050100 ()


  • Interspinous spinal fixation implant
MIS Fusion Plate with HA Coating
Spinal Simplicity, LLC
10-0005-008
In Commercial Distribution

  • M9431000050080 ()


  • Interspinous spinal fixation implant
O-RING WITH CYLINDER FOR EQUATOR ATTACHMENT
JJGC Indústria e Comércio de Materiais Dentários S/A.
102.107
In Commercial Distribution

  • 07898237560878 ()
102.107

  • Dental implant suprastructure, permanent, preformed
ST FiberTag TightRope with Curved NDL
ARTHREX, INC.
AR-1588PFC
In Commercial Distribution

  • 00888867499072 ()
AR-1588PFC

  • Tendon/ligament bone anchor, non-bioabsorbable
ST FiberTag TightRope with Straight NDL
ARTHREX, INC.
AR-1588PF
In Commercial Distribution

  • 00888867499065 ()
AR-1588PF

  • Tendon/ligament bone anchor, non-bioabsorbable
MINI PLUS WITH BLACK COBRAID CARTRIDGE
Smith & Nephew, Inc.
OM-6008
In Commercial Distribution

  • 00817470001068 ()
OM-6008

  • Tendon/ligament bone anchor, non-bioabsorbable
Programmable Valve Cylindrical Valve with prechamber
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
823110
In Commercial Distribution

82-3110

  • Cerebrospinal fluid shunt valve
Medial Suture Anchor with Needles, PEEK
MEDLINE INDUSTRIES, INC.
27-11165
In Commercial Distribution

  • 00818614021379 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 15 Millimeter


  • Tendon/ligament bone anchor, non-bioabsorbable
1.5mm Polymer Cable with Ti Clasp
Kinamed, Inc.
35-100-1040
In Commercial Distribution

  • 00818720011349 ()
  • 40818720011347 ()
  • 30818720011340 ()
35-100-1040

  • Orthopaedic bone cerclage cable
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