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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K-Files, #35 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
DKF21/35
Not in Commercial Distribution

  • H834DKF21351 ()
  • 10381780485209 ()
  • 00381780485202 ()
DKF21/35

  • Manual endodontic file/rasp, single-use
Reduction 7.5 * 35
Medynus, Inc
FPR-75035
In Commercial Distribution

  • 00810088651809 ()
FPR-75035

  • Bone-screw internal spinal fixation system, non-sterile
Reduction 7.0 * 35
Medynus, Inc
FPR-70035
In Commercial Distribution

  • 00810088651588 ()
FPR-70035

  • Bone-screw internal spinal fixation system, non-sterile
Reduction 6.5 * 35
Medynus, Inc
FPR-65035
In Commercial Distribution

  • 00810088651366 ()
FPR-65035

  • Bone-screw internal spinal fixation system, non-sterile
Reduction 6.0 * 35
Medynus, Inc
FPR-60035
In Commercial Distribution

  • 00810088651144 ()
FPR-60035

  • Bone-screw internal spinal fixation system, non-sterile
Reduction 5.5 * 35
Medynus, Inc
FPR-55035
In Commercial Distribution

  • 00810088651052 ()
FPR-55035

  • Bone-screw internal spinal fixation system, non-sterile
Regular 6.5 * 35
Medynus, Inc
FPG-65035
In Commercial Distribution

  • 00810088650215 ()
FPG-65035

  • Bone-screw internal spinal fixation system, non-sterile
Regular 5.5 * 35
Medynus, Inc
FPG-55035
In Commercial Distribution

  • 00810088650123 ()
FPG-55035

  • Bone-screw internal spinal fixation system, non-sterile
IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35
MEDLINE INDUSTRIES, INC.
DYNDTB1516
In Commercial Distribution

  • 20197344105684 ()
  • 10197344105687 ()
DYNDTB1516

  • Medication transfer needle, filtering/vented
HYH,-,MASK,-,-,35
O&M HALYARD, INC.
46728
In Commercial Distribution

  • 30680651467288 ()
  • 20680651467281 ()
  • 90680651467280 ()
46728

  • Surgical/medical respirator, non-antimicrobial, single-use
Short Bevel 35 w/Integrated | Cable Wand; 35 deg.
Provision
STAC2823-01
In Commercial Distribution

  • 00810041063243 ()
STAC2823-01

  • Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed
Easyliner - Size 26
Alps South, LLC
ELPX-26
In Commercial Distribution

  • 00713980002925 ()


  • External limb prosthesis socket liner
DMB LU 26
World Class Technology Corporation
33.30.110.00026
In Commercial Distribution

  • 00840273918103 ()
33.30.110.00026

  • Orthodontic metal band
DMB RL 26
World Class Technology Corporation
33.30.220.00026
In Commercial Distribution

  • 00840273918448 ()
33.30.220.00026

  • Orthodontic metal band
DMB RU 26
World Class Technology Corporation
33.30.120.00026
In Commercial Distribution

  • 00840273917762 ()
33.30.120.00026

  • Orthodontic metal band
26" LIGHT EXTRUSION
AADCO MEDICAL, INC.
OSP-L26
In Commercial Distribution

  • 00840348505474 ()
OSP-L26

  • Custom-made medical device mount
Obturator, 26 Fr.
OLYMPUS Winter & Ibe GmbH
A22082A
In Commercial Distribution

  • 04042761021166 ()
A22082A

  • Rigid endoscope obturator
curved 26 cm
Spiggle & Theis Medizintechnik GmbH
40-475-26
In Commercial Distribution

  • 04250381888759 ()
40-475-26

  • Dressing/utility forceps, scissors-like, reusable
Silicone Tubing 26"
BIOSEAL
19769/20
In Commercial Distribution

  • 10630094197699 ()
  • 00630094197692 ()


  • Suction/irrigation tubing, single-use
CHISEL BLACK, #26
BMT Medizintechnik GmbH
716-201
In Commercial Distribution

  • 04251725201197 ()
716-201

  • Dental osteotome
26 Shade Kit
Dentsply International Inc.
PZ Shade Series Shades
Not in Commercial Distribution

  • D0015030010 ()
503001

  • Dental appliance fabrication material, ceramic
22/26 PLUG
MEDTRONIC SOFAMOR DANEK, INC.
Y0999-026
Not in Commercial Distribution

  • 00681490000628 ()


  • Surgical screwdriver, reusable
20/26 PLUG
MEDTRONIC SOFAMOR DANEK, INC.
Y0999-023
Not in Commercial Distribution

  • 00681490000598 ()


  • Surgical screwdriver, reusable
18/26 PLUG
MEDTRONIC SOFAMOR DANEK, INC.
Y0999-020
Not in Commercial Distribution

  • 00681490000567 ()


  • Surgical screwdriver, reusable
16/26 PLUG
MEDTRONIC SOFAMOR DANEK, INC.
Y0999-017
Not in Commercial Distribution

  • 00681490000536 ()


  • Surgical screwdriver, reusable
Osteotom size 2-6
implantcast GmbH
42230060
In Commercial Distribution

  • 04048844043261 ()


  • Orthopaedic osteotome
26/27S Burnisher
PDT, INC.
R332 26/27S Burnisher
In Commercial Distribution

  • 00813677021762 ()
R332

  • Manual dental burnisher, reusable
Cement Spatula #26
POMEE CORPORATION
713-126
In Commercial Distribution

  • G1577131260 ()
713-126

  • Dental spatula, reusable
ELEVATOR CRYER 26
DARBY DENTAL SUPPLY, LLC
9511755
In Commercial Distribution

  • 00889813038307 ()
9511755

  • Periosteal elevator, reusable
#26/27S Ball
Zoll-Dental
OPB-26/27S
In Commercial Distribution

  • 00840105206194 ()


  • Manual dental burnisher, reusable
#25/26 Ball
Zoll-Dental
OPB-25/26
In Commercial Distribution

  • 00840105206170 ()


  • Manual dental burnisher, reusable
dentaform® Band, tooth 26, size 26/Roth 18
DENTAURUM GmbH & Co.KG
883-326-18
In Commercial Distribution

  • J011883326180 ()


  • Orthodontic metal band
dentaform® Band, Tooth 26, Size 26/Roth 22
DENTAURUM GmbH & Co.KG
883-026-22
Not in Commercial Distribution

  • J011883026220 ()


  • Orthodontic metal band
dentaform® Band, tooth 26, size 26/Roth 22
DENTAURUM GmbH & Co.KG
883-326-22
In Commercial Distribution

  • J011883326220 ()


  • Orthodontic metal band
dentaform® Band, Tooth 26, Size 26/Roth 18
DENTAURUM GmbH & Co.KG
883-026-18
Not in Commercial Distribution

  • J011883026180 ()


  • Orthodontic metal band
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150-3
In Commercial Distribution

  • 00856743007048 ()
150-3

  • Multiple cardiac marker IVD, control
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150-2
In Commercial Distribution

  • 00856743007031 ()
150-2

  • Multiple cardiac marker IVD, control
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150-1
In Commercial Distribution

  • 00856743007024 ()
150-1

  • Multiple cardiac marker IVD, control
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150
In Commercial Distribution

  • 00856743007017 ()
150

  • Multiple cardiac marker IVD, control
ISE CLEANING AND SODIUM ELECTRODE CONDITIONER
ALFA WASSERMANN, INC.
SA1028
In Commercial Distribution

  • 00857969006655 ()
SA1028

  • Wash/cleaning solution IVD, automated/semi-automated system
ISE WASH
ALFA WASSERMANN, INC.
SA1027
In Commercial Distribution

  • 00857969006648 ()
SA1027

  • Multiple electrolyte IVD, calibrator
CAL A
ALFA WASSERMANN, INC.
SA1029
In Commercial Distribution

  • 00857969006389 ()
SA1029

  • Multiple electrolyte IVD, calibrator
REFERENCE ELECTRODE SOLUTION
ALFA WASSERMANN, INC.
E1-3
In Commercial Distribution

  • 00857969006327 ()
E1-3

  • Ion selective electrode (ISE) reference solution IVD, reagent
CAL B
ALFA WASSERMANN, INC.
E1-2
In Commercial Distribution

  • 00857969006310 ()
E1-2

  • Multiple electrolyte IVD, calibrator
Total Protein Reagent
ALFA WASSERMANN, INC.
SA1022
In Commercial Distribution

  • 00857969006235 ()
SA1022

  • Total protein IVD, reagent
Albumin Reagent
ALFA WASSERMANN, INC.
SA2001
In Commercial Distribution

  • 00857969006136 ()
SA2001

  • Albumin IVD, reagent
Creatinine Reagent
ALFA WASSERMANN, INC.
SA1012
In Commercial Distribution

  • 00857969006112 ()
SA1012

  • Creatinine IVD, reagent
Calcium-Arsenazo Reagent
ALFA WASSERMANN, INC.
SA1009
In Commercial Distribution

  • 00857969006105 ()
SA1009

  • Calcium (Ca2+) IVD, reagent
Total Bilirubin Reagent
ALFA WASSERMANN, INC.
SA1008
In Commercial Distribution

  • 00857969006099 ()
SA1008

  • Total bilirubin IVD, reagent
Direct Bilirubin Reagent
ALFA WASSERMANN, INC.
SA1007
In Commercial Distribution

  • 00857969006082 ()
SA1007

  • Conjugated (direct) bilirubin IVD, reagent
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