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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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EDENTA - E312174256540451

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.25.654.045
In Commercial Distribution

  • E31217425654045101 ()
  • E312174256540451 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E312174256540401

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.25.654.040
In Commercial Distribution

  • E31217425654040101 ()
  • E312174256540401 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E312174256540351

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.25.654.035
In Commercial Distribution

  • E31217425654035101 ()
  • E312174256540351 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E312174256540301

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.25.654.030
In Commercial Distribution

  • E31217425654030101 ()
  • E312174256540301 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E312174256540251

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.25.654.025
In Commercial Distribution

  • E31217425654025101 ()
  • E312174256540251 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E312174256540201

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.25.654.020
In Commercial Distribution

  • E31217425654020101 ()
  • E312174256540201 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E312174256540151

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.25.654.015
In Commercial Distribution

  • E31217425654015101 ()
  • E312174256540151 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E312174256540101

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.25.654.010
In Commercial Distribution

  • E31217425654010101 ()
  • E312174256540101 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E312174256540081

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.25.654.008
In Commercial Distribution

  • E31217425654008101 ()
  • E312174256540081 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E31217421654SO21

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.21.654SO2
In Commercial Distribution

  • E31217421654SO21 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E31217421654SO11

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.21.654SO1
In Commercial Distribution

  • E31217421654SO11 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E312174216540801

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.21.654.080
In Commercial Distribution

  • E31217421654080101 ()
  • E312174216540801 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E312174216540701

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.21.654.070
In Commercial Distribution

  • E31217421654070101 ()
  • E312174216540701 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E312174216540601

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.21.654.060
In Commercial Distribution

  • E31217421654060101 ()
  • E312174216540601 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E312174216540551

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.21.654.055
In Commercial Distribution

  • E31217421654055101 ()
  • E312174216540551 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E312174216540501

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.21.654.050
In Commercial Distribution

  • E31217421654050101 ()
  • E312174216540501 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E312174216540451

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.21.654.045
In Commercial Distribution

  • E31217421654045101 ()
  • E312174216540451 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E312174216540401

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.21.654.040
In Commercial Distribution

  • E31217421654040101 ()
  • E312174216540401 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E312174216540351

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.21.654.035
In Commercial Distribution

  • E31217421654035101 ()
  • E312174216540351 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E312174216540301

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.21.654.030
In Commercial Distribution

  • E31217421654030101 ()
  • E312174216540301 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E312174216540251

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.21.654.025
In Commercial Distribution

  • E31217421654025101 ()
  • E312174216540251 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E312174216540201

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.21.654.020
In Commercial Distribution

  • E31217421654020101 ()
  • E312174216540201 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E312174216540151

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.21.654.015
In Commercial Distribution

  • E31217421654015101 ()
  • E312174216540151 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E312174216540101

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.21.654.010
In Commercial Distribution

  • E31217421654010101 ()
  • E312174216540101 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E312174216540081

Hedstroem File with handle
EDENTA ETABLISSEMENT
174.21.654.008
In Commercial Distribution

  • E31217421654008101 ()
  • E312174216540081 ()


  • Manual endodontic file/rasp, reusable

Rhausler - 08500591410520

Plate Bender with Anvil
Rhausler Inc.
C-7056
In Commercial Distribution

  • 08500591410520 ()
C-7056

  • Spinal fixation plate, non-bioabsorbable

N/A - 00840239800398

Tray Lid - With Logo
ADVANCED RESEARCH MEDICAL LLC
00-L1
In Commercial Distribution

  • 00840239800398 ()
00-L1

  • Instrument tray, reusable

EDENTA - E312910711654SO11

Nerve broache with handle
EDENTA ETABLISSEMENT
9107.11.654SO1
In Commercial Distribution

  • E312910711654SO11 ()


  • Endodontic broach, serrated, reusable

EDENTA - E3129107116540601

Nerve broache with handle
EDENTA ETABLISSEMENT
9107.11.654.060
In Commercial Distribution

  • E312910711654060101 ()
  • E3129107116540601 ()


  • Endodontic broach, serrated, reusable

EDENTA - E3129107116540501

Nerve broache with handle
EDENTA ETABLISSEMENT
9107.11.654.050
In Commercial Distribution

  • E312910711654050101 ()
  • E3129107116540501 ()


  • Endodontic broach, serrated, reusable

EDENTA - E3129107116540401

Nerve broache with handle
EDENTA ETABLISSEMENT
9107.11.654.040
In Commercial Distribution

  • E312910711654040101 ()
  • E3129107116540401 ()


  • Endodontic broach, serrated, reusable

EDENTA - E3129107116540351

Nerve broache with handle
EDENTA ETABLISSEMENT
9107.11.654.035
In Commercial Distribution

  • E312910711654035101 ()
  • E3129107116540351 ()


  • Endodontic broach, serrated, reusable

EDENTA - E3129107116540301

Nerve broache with handle
EDENTA ETABLISSEMENT
9107.11.654.030
In Commercial Distribution

  • E312910711654030101 ()
  • E3129107116540301 ()


  • Endodontic broach, serrated, reusable

EDENTA - E3129107116540251

Nerve broache with handle
EDENTA ETABLISSEMENT
9107.11.654.025
In Commercial Distribution

  • E312910711654025101 ()
  • E3129107116540251 ()


  • Endodontic broach, serrated, reusable

EDENTA - E3129107116540201

Nerve broache with handle
EDENTA ETABLISSEMENT
9107.11.654.020
In Commercial Distribution

  • E312910711654020101 ()
  • E3129107116540201 ()


  • Endodontic broach, serrated, reusable

General Instruments - 00840180524008

Allograft Inserter with Stop
ALPHATEC SPINE, INC.
CI-11441
In Commercial Distribution

  • 00840180524008 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

General Instrument - 00840180516256

Funnel with Depth Markings
ALPHATEC SPINE, INC.
CI-10229
In Commercial Distribution

  • 00840180516256 ()


  • Bone graft funnel

Stingray™ - 08714729837541

Guidewire with Hydrophilic Coating
BOSTON SCIENTIFIC CORPORATION
H749M3012A0
In Commercial Distribution

  • 08714729837541 ()

  • 185 cm Length
  • 0.014 in Diameter


  • Cardiac/peripheral vascular guidewire, single-use

Stingray™ - 08714729837527

Guidewire with Hydrophilic Coating
BOSTON SCIENTIFIC CORPORATION
H749M3004A0
In Commercial Distribution

  • 08714729837527 ()

  • 0.014 in Diameter
  • 300 cm Length


  • Cardiac/peripheral vascular guidewire, single-use

Innomed, Inc. - 00840277128027

Screw Extractor with Speedlock
INNOMED, INC.
2021
In Commercial Distribution

  • 00840277128027 ()
2021

  • Surgical flat-nosed pliers

Innomed, Inc. - 00840277127150

Articulated Caliper with Ruler
INNOMED, INC.
2026-00
In Commercial Distribution

  • 00840277127150 ()
2026-00

  • Tape measure, reusable

Innomed, Inc. - 00840277127099

Pituitary Rongeur with Teeth
INNOMED, INC.
1792
In Commercial Distribution

  • 00840277127099 ()
1792

  • Orthopaedic inorganic implant inserter/extractor, reusable

Innomed, Inc. - 00840277126689

4" Blade with Teeth
INNOMED, INC.
C1013-01
In Commercial Distribution

  • 00840277126689 ()
C1013-01

  • Hand-held surgical retractor, reusable

Innomed, Inc. - 00840277125279

2.5" Blade with Teeth
INNOMED, INC.
C1013
In Commercial Distribution

  • 00840277125279 ()
C1013

  • Hand-held surgical retractor, reusable

Innomed, Inc. - 00840277129529

Lobster Clamp with Speedlock
INNOMED, INC.
AR-7650-36
In Commercial Distribution

  • 00840277129529 ()
AR-7650-36

  • Bone approximation clamp

Innomed, Inc. - 00840277125576

Bone Clamp with Speedlock
INNOMED, INC.
3659
In Commercial Distribution

  • 00840277125576 ()
3659

  • Bone approximation clamp

Innomed, Inc. - 00840277130037

Screwdriver with Quick Connect
INNOMED, INC.
2027-03
In Commercial Distribution

  • 00840277130037 ()
2027-03

  • Surgical screwdriver, reusable

Innomed, Inc. - 00840277130020

T-Handle with Quick Connect
INNOMED, INC.
2027-02
In Commercial Distribution

  • 00840277130020 ()
2027-02

  • Orthopaedic inorganic implant inserter/extractor, reusable

Vaginal CT/MR Multi Channel Applicator - 08717213022492

Catheter with collar 6Fx293
Nucletron B.V.
110802-00
In Commercial Distribution

  • 08717213022423 ()
  • 08717213022492 ()

  • Catheter Gauge: 6.0 French
  • Device Size Text, specify:
  • Length: 293.0 Millimeter


  • Cervical/intrauterine brachytherapy system applicator, remote-afterloading

Therabody - 00840295403342

Sleeping Mask with vibration
Therabody, Inc.
Sleep Mask
In Commercial Distribution

  • 00840295403342 ()


  • Hand-held electric massager
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