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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Adapter1.5DiaX4.7InLg W/Two 125 Slots
DEROYAL INDUSTRIES, INC.
BE1-L
In Commercial Distribution

  • 50749756954971 ()
  • 00749756954976 ()


  • Instrument/equipment drape, single-use, sterile
Two Level, Standard Plate, 41mm
Pioneer Surgical Technology, Inc.
27-241
Not in Commercial Distribution

  • 00846468050917 ()
27-241

  • Bone-screw internal spinal fixation system, non-sterile
  • Spinal fixation plate, non-bioabsorbable
Two Level, Standard Plate, 38mm
Pioneer Surgical Technology, Inc.
27-238
Not in Commercial Distribution

  • 00846468050900 ()
27-238

  • Bone-screw internal spinal fixation system, non-sterile
  • Spinal fixation plate, non-bioabsorbable
Two Level, Standard Plate, 36mm
Pioneer Surgical Technology, Inc.
27-236
Not in Commercial Distribution

  • 00846468050894 ()
27-236

  • Bone-screw internal spinal fixation system, non-sterile
  • Spinal fixation plate, non-bioabsorbable
Two Level, Standard Plate, 34mm
Pioneer Surgical Technology, Inc.
27-234
Not in Commercial Distribution

  • 00846468050887 ()
27-234

  • Spinal fixation plate, non-bioabsorbable
  • Bone-screw internal spinal fixation system, non-sterile
Two Level, Standard Plate, 32mm
Pioneer Surgical Technology, Inc.
27-232
Not in Commercial Distribution

  • 00846468050870 ()
27-232

  • Bone-screw internal spinal fixation system, non-sterile
  • Spinal fixation plate, non-bioabsorbable
Two Level, Standard Plate, 30mm
Pioneer Surgical Technology, Inc.
27-230
Not in Commercial Distribution

  • 00846468050863 ()
27-230

  • Bone-screw internal spinal fixation system, non-sterile
  • Spinal fixation plate, non-bioabsorbable
Two Level, Standard Plate, 28mm
Pioneer Surgical Technology, Inc.
27-228
Not in Commercial Distribution

  • 00846468050856 ()
27-228

  • Bone-screw internal spinal fixation system, non-sterile
  • Spinal fixation plate, non-bioabsorbable
Two Level, Standard Plate, 26mm
Pioneer Surgical Technology, Inc.
27-226
Not in Commercial Distribution

  • 00846468050849 ()
27-226

  • Bone-screw internal spinal fixation system, non-sterile
  • Spinal fixation plate, non-bioabsorbable
ARX Two Step Breakaway T-Handle
Life Spine, Inc.
113-419
In Commercial Distribution

  • 00190837035426 ()
113-419

  • Bone-screw internal spinal fixation system, non-sterile
ARX Two Step Switching Stick
Life Spine, Inc.
113-417
In Commercial Distribution

  • 00190837035419 ()
113-417

  • Bone-screw internal spinal fixation system, non-sterile
SKIN HOOK SET OF TWO
DEPUY ORTHOPAEDICS, INC.
2841-10-000
In Commercial Distribution

  • 10603295155010 ()
284110000

  • Hand-held surgical retractor, reusable
Two Tank Shuttle Valve System
Bracco Diagnostics Inc.
710602
In Commercial Distribution

  • 30815112021703 ()
710602

  • Gastrointestinal endoscopic insufflator
Shorty Two Speed Air Motor
SIRONA Dental Systems GmbH
710024D
In Commercial Distribution

  • E276710024D0 ()


  • Dental surgical power tool motorized handpiece/set, pneumatic
INFINITY INTERNAL HEX SURGICAL TRAY
ACE SURGICAL SUPPLY CO., INC.
3505222
In Commercial Distribution

  • 00614950013739 ()
3505222

  • Surgical instrument interim-placement holder, reusable
infinity INTERNAL HEX SURGICAL KIT
ACE SURGICAL SUPPLY CO., INC.
20992016
In Commercial Distribution

  • 00614950026715 ()
20992016

  • Dental torque wrench
MUA INTERNAL HEX PROSTHETIC SCREW
ACE SURGICAL SUPPLY CO., INC.
MUS0014
In Commercial Distribution

  • 00614950027439 ()
MUS0014

  • Dental implant suprastructure, permanent, preformed
Internal Direct Coping Screw, XL
BIOHORIZONS IMPLANT SYSTEMS, INC
PXDCSL
In Commercial Distribution

  • 00847236005696 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Internal 4.5mm Laser-Lok Protective Sleeve
BIOHORIZONS IMPLANT SYSTEMS, INC
PGTBLS
In Commercial Distribution

  • 00847236005450 ()


  • Manual non-rotary dental instrument handle
Internal 4.5mm Titanium Base Abutment
BIOHORIZONS IMPLANT SYSTEMS, INC
PGTB
In Commercial Distribution

  • 00847236005436 ()


  • Dental implant suprastructure, permanent, preformed
Internal 4.5mm Straight Esthetic Abutment
BIOHORIZONS IMPLANT SYSTEMS, INC
PGSEA
In Commercial Distribution

  • 00847236005399 ()


  • Dental implant suprastructure, permanent, preformed
Internal 4.5 Plastic Temporary Abutment
BIOHORIZONS IMPLANT SYSTEMS, INC
PGRTA
In Commercial Distribution

  • 00847236005382 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Internal 4.5 Narrow Emergence Abutment
BIOHORIZONS IMPLANT SYSTEMS, INC
PGNEA
In Commercial Distribution

  • 00847236005191 ()


  • Dental implant suprastructure, permanent, preformed
Internal 5.7 Narrow Emergence Abutment
BIOHORIZONS IMPLANT SYSTEMS, INC
PBNEA
In Commercial Distribution

  • 00847236004644 ()


  • Dental implant suprastructure, permanent, preformed
Internal 5.7mm Bulk Prep Abutment
BIOHORIZONS IMPLANT SYSTEMS, INC
PBBPA
In Commercial Distribution

  • 00847236004545 ()


  • Dental implant suprastructure, permanent, preformed
Internal 5.7mm Ball-top Abutment Analog
BIOHORIZONS IMPLANT SYSTEMS, INC
PBBAA
In Commercial Distribution

  • 00847236004538 ()


  • Dental implant abutment analog, laboratory
Internal 5.7mm Platform Analog Handle
BIOHORIZONS IMPLANT SYSTEMS, INC
PBAH
In Commercial Distribution

  • 00847236004507 ()
  • 00847236020019 ()


  • Manual non-rotary dental instrument handle
Internal 5.7mm Angled Esthetic Abutment
BIOHORIZONS IMPLANT SYSTEMS, INC
PBAEA
In Commercial Distribution

  • 00847236004453 ()


  • Dental implant suprastructure, permanent, preformed
Internal 3.0mm Ball-top Abutment Analog
BIOHORIZONS IMPLANT SYSTEMS, INC
TP3BAA
In Commercial Distribution

  • 00847236004026 ()


  • Dental implant abutment analog, laboratory
Tapered Internal HD Surgical Tray
BIOHORIZONS IMPLANT SYSTEMS, INC
TSK3500
In Commercial Distribution

  • 00847236011314 ()


  • Instrument tray, reusable
Tapered Internal HD Surgical Kit
BIOHORIZONS IMPLANT SYSTEMS, INC
TSK4000
In Commercial Distribution

  • 00847236011161 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Internal 3.0mm Laser-Lok Protective Sleeve
BIOHORIZONS IMPLANT SYSTEMS, INC
TP3TBLS
In Commercial Distribution

  • 00847236010843 ()


  • Manual non-rotary dental instrument handle
Internal 3.5mm Laser-Lok Protective Sleeve
BIOHORIZONS IMPLANT SYSTEMS, INC
PYTBLS
In Commercial Distribution

  • 00847236006259 ()


  • Manual non-rotary dental instrument handle
Internal 3.5mm Titanium Base Abutment
BIOHORIZONS IMPLANT SYSTEMS, INC
PYTB
In Commercial Distribution

  • 00847236006235 ()


  • Dental implant suprastructure, permanent, preformed
Internal 3.5mm Straight Esthetic Abutment
BIOHORIZONS IMPLANT SYSTEMS, INC
PYSEA
In Commercial Distribution

  • 00847236006198 ()


  • Dental implant suprastructure, permanent, preformed
Internal 3.5 Plastic Temporary Abutment
BIOHORIZONS IMPLANT SYSTEMS, INC
PYRTA
In Commercial Distribution

  • 00847236006181 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Internal 3.5 Narrow Emergence Abutment
BIOHORIZONS IMPLANT SYSTEMS, INC
PYNEA
In Commercial Distribution

  • 00847236005993 ()


  • Dental implant suprastructure, permanent, preformed
Internal 3.5mm Bulk Prep Abutment
BIOHORIZONS IMPLANT SYSTEMS, INC
PYBPA
In Commercial Distribution

  • 00847236005832 ()


  • Dental implant suprastructure, permanent, preformed
Internal 3.5mm Angled Esthetic Abutment
BIOHORIZONS IMPLANT SYSTEMS, INC
PYAEA
In Commercial Distribution

  • 00847236005740 ()


  • Dental implant suprastructure, permanent, preformed
Internal 4.5mm Bulk Prep Abutment
BIOHORIZONS IMPLANT SYSTEMS, INC
PGBPA
In Commercial Distribution

  • 00847236005054 ()


  • Dental implant suprastructure, permanent, preformed
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