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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Finger Pulse Oximeter
GF HEALTH PRODUCTS, INC.
JB02020
In Commercial Distribution

  • M368020202 ()
  • M368JB020201 ()
JB02020

  • Pulse oximeter
OxyRead Finger Pulse Oximeter
GF HEALTH PRODUCTS, INC.
JB02017
In Commercial Distribution

  • M368JB020171 ()
  • M368JB020172 ()


  • Pulse oximeter
DigiOx Finger Pulse Oximeter
GF HEALTH PRODUCTS, INC.
JB02008
In Commercial Distribution

  • M368JB020081 ()
  • M368JB020082 ()


  • Pulse oximeter
NEB-U-TYKE RR TRAIN
GF HEALTH PRODUCTS, INC.
JB0112-164
In Commercial Distribution

  • M368JB01121642 ()
  • M368JB01121641 ()


  • Benchtop nebulizer, non-heated
Neb-u-LiteLX3 Nebulite Compressor
GF HEALTH PRODUCTS, INC.
JB0112-111
In Commercial Distribution

  • M368JB01121112 ()
  • M368JB01121111 ()
JB0112-111

  • Benchtop nebulizer, non-heated
Neb-u-Lite LX Nebulizer Compressor
GF HEALTH PRODUCTS, INC.
JB0112-110
In Commercial Distribution

  • M368JB01121101 ()
  • M368JB01121102 ()


  • Benchtop nebulizer, non-heated
Neb-u-Lite EV2 Nebulizer
GF HEALTH PRODUCTS, INC.
JB0112-090
In Commercial Distribution

  • M368JB01120902 ()
  • M368JB01120901 ()


  • Benchtop nebulizer, non-heated
Neb-u-Tyke Nebulizer Compressor
GF HEALTH PRODUCTS, INC.
JB0112-071
In Commercial Distribution

  • M368JB01120712 ()
  • M368JB01120711 ()


  • Benchtop nebulizer, non-heated
NEB-U-TYKE NEB-A-DOODLE
GF HEALTH PRODUCTS, INC.
JB0112-070
In Commercial Distribution

  • M368JB01120702 ()
  • M368JB01120701 ()


  • Benchtop nebulizer, non-heated
NEB-U-TYKE SPEEDSTER
GF HEALTH PRODUCTS, INC.
JB0112-067
In Commercial Distribution

  • M368JB01120672 ()
  • M368JB01120671 ()


  • Benchtop nebulizer, non-heated
NEB-U-TYKE IC Penguin
GF HEALTH PRODUCTS, INC.
JB0112-062
In Commercial Distribution

  • M368JB01120622 ()
  • M368JB01120621 ()


  • Benchtop nebulizer, non-heated
NEB-U-LITE EV
GF HEALTH PRODUCTS, INC.
JB0112-061
In Commercial Distribution

  • M368JB01120612 ()
  • M368JB01120611 ()


  • Benchtop nebulizer, non-heated
Vacutec 800 EV
GF HEALTH PRODUCTS, INC.
JB0112-016
In Commercial Distribution

  • M368JB01120162 ()
  • M368JB01120161 ()


  • General-purpose suction system, line-powered
Self-Drilling Screw - Low-Profile - 4 mm (6) [5 PK]
Bioplate, Inc.
81-7323
In Commercial Distribution

  • M3848173231 ()
  • M3848173230 ()
81-7323

  • Neurosurgical procedure kit, non-medicated, single-use
Self-Drilling Screw - Low-Profile - 4 mm (4) [5 PK]
Bioplate, Inc.
81-7322
In Commercial Distribution

  • M3848173221 ()
  • M3848173220 ()
81-7322

  • Neurosurgical procedure kit, non-medicated, single-use
Straight Plate - Ø1.9 mm - 2 hole - 15 mm (1) [5 PK]
Bioplate, Inc.
81-7314
In Commercial Distribution

  • M3848173141 ()
  • M3848173140 ()
81-7314

  • Neurosurgical procedure kit, non-medicated, single-use
Self-Drilling Screw - Ø1.9 mm x 4 mm (2) [5 PK]
Bioplate, Inc.
81-7311
In Commercial Distribution

  • M3848173111 ()
  • M3848173110 ()
81-7311

  • Neurosurgical procedure kit, non-medicated, single-use
Straight Plate - Ø1.9 mm - 2 hole - 15 mm (3), Self-Drilling Screw - 4 mm (6) [10 PK]
Bioplate, Inc.
81-7307
In Commercial Distribution

  • M3848173071 ()
  • M3848173070 ()
81-7307

  • Neurosurgical procedure kit, non-medicated, single-use
Straight Plate - Ø1.5 mm - 2 hole - 14 mm (1) [5 PK]
Bioplate, Inc.
81-7304
In Commercial Distribution

  • M3848173041 ()
  • M3848173040 ()
81-7304

  • Neurosurgical procedure kit, non-medicated, single-use
Flexible Burr Hole Cover - Ø1.5 mm - 18 mm (1) [10 PK]
Bioplate, Inc.
81-5903
In Commercial Distribution

  • M3848159031 ()
  • M3848159030 ()
81-5903

  • Neurosurgical procedure kit, non-medicated, single-use
Boxcar Plate - Ø1.5 mm - 4 hole - 10 x 10 mm (1) [10 PK]
Bioplate, Inc.
81-5902
In Commercial Distribution

  • M3848159021 ()
  • M3848159020 ()
81-5902

  • Neurosurgical procedure kit, non-medicated, single-use
X Plate - Ø1.5 mm - 6 hole - 17 mm (1) [10 PK]
Bioplate, Inc.
81-5901
In Commercial Distribution

  • M3848159011 ()
  • M3848159010 ()
81-5901

  • Neurosurgical procedure kit, non-medicated, single-use
Straight Compression Plate - Ø1.5 mm - 2 hole - 14 mm (1) [10 PK]
Bioplate, Inc.
81-5900
In Commercial Distribution

  • M3848159001 ()
  • M3848159000 ()
81-5900

  • Neurosurgical procedure kit, non-medicated, single-use
Emergency Screw - Ø1.8 mm x 4 mm [10/Pk]
Bioplate, Inc.
81-5898
In Commercial Distribution

  • M3848158981 ()
  • M3848158980 ()
81-5898

  • Neurosurgical procedure kit, non-medicated, single-use
Self-Drilling Screw - Low-Profile - 5 mm (2) [5 PK]
Bioplate, Inc.
81-5891
In Commercial Distribution

  • M3848158911 ()
  • M3848158910 ()
81-5891

  • Craniofacial bone screw, non-bioabsorbable
Self-Drilling Screw - Low-Profile - 4 mm (2) [5 PK]
Bioplate, Inc.
81-5890
In Commercial Distribution

  • M3848158901 ()
  • M3848158900 ()
81-5890

  • Craniofacial bone screw, non-bioabsorbable
Self-Drilling Screw - Low-Profile - 3 mm (2) [5 PK]
Bioplate, Inc.
81-5889
In Commercial Distribution

  • M3848158891 ()
  • M3848158890 ()
81-5889

  • Craniofacial bone screw, non-bioabsorbable
Self-Drilling Screw - Ø1.9 mm x 4 mm (2) [10 PK]
Bioplate, Inc.
81-3584
In Commercial Distribution

  • M3848135841 ()
  • M3848135840 ()
81-3584

  • Craniofacial bone screw, non-bioabsorbable
X Plate - Ø1.5 mm - 6 hole - 17 mm (1), Self-Drilling Screw - 4 mm (6) [5 PK]
Bioplate, Inc.
81-3578[US]
In Commercial Distribution

  • M384813578US1 ()
  • M384813578US0 ()
81-3578[US]

  • Neurosurgical procedure kit, non-medicated, single-use
Self-Drilling Screw - Ø1.5 mm x 4 mm (6) [10 PK]
Bioplate, Inc.
81-3577
In Commercial Distribution

  • M3848135771 ()
  • M3848135770 ()
81-3577

  • Craniofacial bone screw, non-bioabsorbable
Self-Drilling Screw - Ø1.5 mm x 4 mm (2) [10 PK]
Bioplate, Inc.
81-3576
In Commercial Distribution

  • M3848135761 ()
  • M3848135760 ()
81-3576

  • Craniofacial bone screw, non-bioabsorbable
Single-Use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
OS-CP-05-12
In Commercial Distribution

  • M397OSCP05120 ()
  • M397OSCP05122 ()

  • Length: 12 Centimeter
OS-CP-05-12

  • Plasma surgical system handpiece
Single-Use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
OS-CP 05-07H
In Commercial Distribution

  • M397OSCP0507H2 ()
  • M397OSCP0507H0 ()

  • Length: 07 Centimeter
OS-CP 05-07H

  • Plasma surgical system handpiece
Single-Use Cut/Coagulation Handpiece for Open Surgery for PlasmaJet System
PLASMA SURGICAL, INC
OS-CP-05-07
In Commercial Distribution

  • M397OSCP05070 ()
  • M397OSCP05072 ()

  • Length: 7 Centimeter
OS-CP-05-07

  • Plasma surgical system handpiece
Single-Use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
OS-CG 05-12H
In Commercial Distribution

  • M397OSCG0512H2 ()
  • M397OSCG0512H0 ()

  • Length: 12 Centimeter
OS-CG 05-12H

  • Plasma surgical system handpiece
Single-Use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
OS-CG-05-12
In Commercial Distribution

  • M397OSCG05120 ()
  • M397OSCG05122 ()

  • Length: 12 Centimeter
OS-CG-05-12

  • Plasma surgical system handpiece
Single-Use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
OS-CG 05-07H
In Commercial Distribution

  • M397OSCG0507H2 ()
  • M397OSCG0507H0 ()

  • Length: 7 Centimeter
OS-CG 05-07H

  • Plasma surgical system handpiece
Single-Use Cut/Coagulation Handpiece for Open Surgery for PlasmaJet System
PLASMA SURGICAL, INC
OS-CG-05-07
In Commercial Distribution

  • M397OSCG05072 ()
  • M397OSCG05070 ()

  • Length: 7 Centimeter
OS-CG-05-07

  • Plasma surgical system handpiece
Single-Use Cut/Coagulation Handpiece for Laparoscopic Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
LS-CP 05-28H
In Commercial Distribution

  • M397LSCP0528H2 ()
  • M397LSCP0528H0 ()

  • Length: 28 Centimeter
LS-CP 05-28H

  • Plasma surgical system handpiece
Single-Use Cut/Coagulation Handpiece for Laparoscopic Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
LS-CG 05-28H
In Commercial Distribution

  • M397LSCG0528H2 ()
  • M397LSCG0528H0 ()

  • Length: 28 Centimeter
LS-CG 05-28H

  • Plasma surgical system handpiece
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