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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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
Femoral Aimer 35
Medacta International SA
05.05.10.0015
In Commercial Distribution

  • 07630040729345 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
PAC400, 35 cm
PENUMBRA, INC.
400PAC35
In Commercial Distribution

  • 00815948021327 ()
400PAC35

  • Neurovascular embolization coil
K-Files, #35 31mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
DKF31/35
Not in Commercial Distribution

  • H834DKF31351 ()
  • 10381780485506 ()
  • 00381780485509 ()
DKF31/35

  • Manual endodontic file/rasp, single-use
K-Files, #35 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
DKF25/35
Not in Commercial Distribution

  • H834DKF25351 ()
  • 10381780485353 ()
  • 00381780485356 ()
DKF25/35

  • Manual endodontic file/rasp, single-use
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
HYH,-,MASK,-,-,35
O&M HALYARD, INC.
46728
In Commercial Distribution

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

  • Surgical/medical respirator, non-antimicrobial, single-use
IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35
MEDLINE INDUSTRIES, INC.
DYNDTB1516
In Commercial Distribution

  • 20197344105684 ()
  • 10197344105687 ()
DYNDTB1516

  • Medication transfer needle, filtering/vented
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
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
curved 26 cm
Spiggle & Theis Medizintechnik GmbH
40-475-26
In Commercial Distribution

  • 04250381888759 ()
40-475-26

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

  • 10630094197699 ()
  • 00630094197692 ()


  • Suction/irrigation tubing, single-use
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
DMB RL 26
World Class Technology Corporation
33.30.220.00026
In Commercial Distribution

  • 00840273918448 ()
33.30.220.00026

  • Orthodontic metal band
DMB LU 26
World Class Technology Corporation
33.30.110.00026
In Commercial Distribution

  • 00840273918103 ()
33.30.110.00026

  • 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
Obturator, 26 Fr.
OLYMPUS Winter & Ibe GmbH
A22082A
In Commercial Distribution

  • 04042761021166 ()
A22082A

  • Rigid endoscope obturator
Osteotom size 2-6
implantcast GmbH
42230060
In Commercial Distribution

  • 04048844043261 ()


  • Orthopaedic osteotome
26" LIGHT EXTRUSION
AADCO MEDICAL, INC.
OSP-L26
In Commercial Distribution

  • 00840348505474 ()
OSP-L26

  • Custom-made medical device mount
Cement Spatula #26
POMEE CORPORATION
713-126
In Commercial Distribution

  • G1577131260 ()
713-126

  • Dental spatula, reusable
26/27S Burnisher
PDT, INC.
R332 26/27S Burnisher
In Commercial Distribution

  • 00813677021762 ()
R332

  • Manual dental burnisher, reusable
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
883-326-18
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 18
DENTAURUM GmbH & Co.KG
883-026-18
Not in Commercial Distribution

  • J011883026180 ()


  • Orthodontic metal band
Sample Purifier Tubes
TRINITY BIOTECH PUBLIC LIMITED COMPANY
591-20
In Commercial Distribution

  • 05391516742207 ()
  • 05391516749602 ()

  • 20 Tubes
591-20

  • Oxalate IVD, reagent
Sample Purifier Tubes
TRINITY BIOTECH PUBLIC LIMITED COMPANY
591-100
In Commercial Distribution

  • 05391516742177 ()
  • 05391516749619 ()

  • 100 Tubes
591-100

  • Oxalate IVD, reagent
Bile Acids Stop Reagent
TRINITY BIOTECH PUBLIC LIMITED COMPANY
450-3
In Commercial Distribution

  • 05391516741910 ()

  • Total Volume: 50 Milliliter
450-3

  • Total bile acid IVD, reagent
Mineral Oil
TRINITY BIOTECH PUBLIC LIMITED COMPANY
400-5-1000
In Commercial Distribution

  • 05391516741699 ()

  • Total Volume: 1000 Milliliter
400-5-1000

  • Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, reagent
Mineral Oil
TRINITY BIOTECH PUBLIC LIMITED COMPANY
400-5-100
In Commercial Distribution

  • 05391516741682 ()

  • Total Volume: 100 Milliliter
400-5-100

  • Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, reagent
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