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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TROCAR PIN TRIANGULAR 5/150MM
Aesculap AG
EK053R
In Commercial Distribution

  • 04046963424947 ()

  • Diameter (mm) : 5.000 MM
  • Working length (mm) : 150.000 MM
EK053R

  • Laparoscopic dilation guide rod
TROCAR PIN TRIANGULAR 5/110MM
Aesculap AG
EK052R
In Commercial Distribution

  • 04046963424930 ()

  • Diameter (mm) : 5.000 MM
  • Working length (mm) : 110.000 MM
EK052R

  • Laparoscopic dilation guide rod
TROCAR PIN TRIANGULAR 5/60MM
Aesculap AG
EK051R
In Commercial Distribution

  • 04046963424916 ()

  • Diameter (mm) : 5.000 MM
  • Working length (mm) : 60.000 MM
EK051R

  • Laparoscopic dilation guide rod
TROCAR PIN CONICAL BLUNT 5/150MM
Aesculap AG
EK050R
In Commercial Distribution

  • 04046963424909 ()

  • Diameter (mm) : 5.000 MM
  • Working length (mm) : 150.000 MM
EK050R

  • Laparoscopic dilation guide rod
TROCAR PIN CONICAL BLUNT 5/110MM
Aesculap AG
EK049R
In Commercial Distribution

  • 04046963424794 ()

  • Diameter (mm) : 5.000 MM
  • Working length (mm) : 110.000 MM
EK049R

  • Laparoscopic dilation guide rod
TROCAR PIN CONICAL BLUNT 5/60MM
Aesculap AG
EK048R
In Commercial Distribution

  • 04046963424787 ()

  • Diameter (mm) : 5.000 MM
  • Working length (mm) : 60.000 MM
EK048R

  • Laparoscopic dilation guide rod
TROCAR PIN CONICAL SHARP 5/150MM
Aesculap AG
EK047R
In Commercial Distribution

  • 04046963424770 ()

  • Diameter (mm) : 5.000 MM
  • Working length (mm) : 150.000 MM
EK047R

  • Laparoscopic dilation guide rod
TROCAR PIN CONICAL SHARP 5/110MM
Aesculap AG
EK046R
In Commercial Distribution

  • 04046963424763 ()

  • Diameter (mm) : 5.000 MM
  • Working length (mm) : 110.000 MM
EK046R

  • Laparoscopic dilation guide rod
TROCAR PIN CONICAL SHARP 5/60MM
Aesculap AG
EK045R
In Commercial Distribution

  • 04046963424756 ()

  • Diameter (mm) : 5.000 MM
  • Working length (mm) : 60.000 MM
EK045R

  • Laparoscopic dilation guide rod
TROCAR PIN CONICAL BLUNT 12/110MM
Aesculap AG
EK069R
In Commercial Distribution

  • 04046963417703 ()

  • Diameter (mm) : 12.000 MM
  • Working length (mm) : 110.000 MM
EK069R

  • Laparoscopic dilation guide rod
TROCAR PIN CONICAL BLUNT 10/110MM
Aesculap AG
EK059R
In Commercial Distribution

  • 04046963417697 ()

  • Diameter (mm) : 10.000 MM
  • Working length (mm) : 110.000 MM
EK059R

  • Laparoscopic dilation guide rod
CONICAL OBTURATOR BLUNT D:13MM 110MM
Aesculap AG
EJ588R
In Commercial Distribution

  • 04046963075576 ()

  • Diameter (mm) : 13.000 MM
  • Working length (mm) : 110.000 MM
EJ588R

  • Laparoscopic dilation guide rod
CONICAL OBTURATOR SHARP D:13MM 110MM
Aesculap AG
EJ587R
Not in Commercial Distribution

  • 04046963075545 ()

  • Diameter (mm) : 13.000 MM
  • Working length (mm) : 110.000 MM
EJ587R

  • Laparoscopic dilation guide rod
TRIANGULAR OBTURATOR D:13MM 110MM
Aesculap AG
EJ586R
In Commercial Distribution

  • 04046963075521 ()

  • Diameter (mm) : 13.000 MM
  • Working length (mm) : 110.000 MM
EJ586R

  • Laparoscopic dilation guide rod
EVOL®SI, 22mm x 140mm Fixed Port Dilator
Cutting Edge Spine, LLC
CES-294
In Commercial Distribution

  • 00841193122458 ()
CES-294

  • Laparoscopic dilation guide rod
EVOL®SI, 22mm x 100mm Fixed Port Dilator
Cutting Edge Spine, LLC
CES-293
In Commercial Distribution

  • 00841193122441 ()
CES-293

  • Laparoscopic dilation guide rod
EVOL®SI, Dilator
Cutting Edge Spine, LLC
CES-292
In Commercial Distribution

  • 00841193122434 ()
CES-292

  • Laparoscopic dilation guide rod
GUIDE TUBE, CURVED, Ø 5 MM (FIT FOR T.0038.05)
Gimmi GmbH
T.0040.05
In Commercial Distribution

  • 04049047546184 ()
T.0040.05

  • Laparoscopic dilation guide rod
Integra® Jarit® Dilation Set, 5-10mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
600475
In Commercial Distribution

  • M2746004751 ()
  • 10381780145653 ()
600-475

  • Laparoscopic dilation guide rod
ARTHROSCOPIC SWITCH STICK
SONTEC INSTRUMENTS, INC.
1271-117-5
In Commercial Distribution

  • 00192896083981 ()

  • Length: 8.75 Inch
  • 2.4 Millimeter Tip
1271-117-5

  • Laparoscopic dilation guide rod
Gutta Percha Points is used to root canal filing material.
DiaDent Group International
DIA-ISOGT-.10 10
In Commercial Distribution

  • 08806383505178 ()
118-602

  • Natural gutta-percha
Surface Applicator End Cap, 10 mm, 10-Pack
Icad, Inc.
720297
In Commercial Distribution

  • 00858012005410 ()
SK3510

  • Intraoperative/postoperative therapeutic x-ray system surface applicator
Talymed 10 cm x 10 cm
Marine Polymer Technologies, Inc.
400-19
In Commercial Distribution

  • 10389142000190 ()
  • 00389142000193 ()


  • Wound regenerating polysaccharide agent
No Description
SCIMEDX CORPORATION
I-HV201X
In Commercial Distribution

  • 00813545025731 ()
I-HV201X

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
SCIMEDX CORPORATION
I-HV101X
In Commercial Distribution

  • 00813545025700 ()
I-HV101X

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
SCIMEDX CORPORATION
I-EBV03X
In Commercial Distribution

  • 00813545025618 ()
I-EBV03X

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Lumipulse G Wash Solution
FUJIREBIO DIAGNOSTICS, INC.
4008248
In Commercial Distribution

  • 00850212007096 ()

  • Size Type = Units Per Kit; Units = 1; Unit of Measure = 1000mLs


  • Buffered wash solution IVD
No Description
FUJIREBIO INC.
260340
In Commercial Distribution

  • 04987270260340 ()

  • Number of tests per kit: 42


  • SARS-CoV-2 antigen IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
235393
In Commercial Distribution

  • 04987270235393 ()

  • Size Type = Tests per Kit; Size Unit = 42; Unit of Measure = Tests


  • Total testosterone IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
235294
Not in Commercial Distribution

  • 04987270235294 ()

  • Size Type = Tests per Kit; Size Unit = 42; Unit of Measure = Tests


  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
235270
Not in Commercial Distribution

  • 04987270235270 ()

  • Size Type = Tests per Kit; Size Unit = 42; Unit of Measure = Tests


  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
235232
In Commercial Distribution

  • 04987270235232 ()

  • Size Type = Tests per Kit; Size Unit = 42; Unit of Measure = Tests


  • Human chorionic gonadotropin beta-core fragment IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
230688
In Commercial Distribution

  • 04987270230688 ()

  • Size Type = Units per Kit; Units = 2; Unit of Measure = 3.0mLs


  • Cancer antigen 125 (CA125) IVD, calibrator
No Description
FUJIREBIO INC.
230664
Not in Commercial Distribution

  • 04987270230664 ()

  • Size Type = Units per Kit; Units = 2; Unit of Measure = 3.0 mLs


  • Cancer antigen 19-9 (CA19-9) IVD, calibrator
No Description
FUJIREBIO INC.
230640
In Commercial Distribution

  • 04987270230640 ()

  • Size Type = Units per kit; Units = 2; Unit of Measure = 3.0 mLs


  • Cancer antigen 15-3 (CA15-3) IVD, calibrator
No Description
FUJIREBIO INC.
230213
Not in Commercial Distribution

  • 04987270230213 ()

  • Size Type = Units per Kit; Units = 4; Unit of Measure = 12mLs


  • Parathyroid hormone (PTH) IVD, control
No Description
FUJIREBIO INC.
230206
Not in Commercial Distribution

  • 04987270230206 ()

  • Size Type =Units per Kit; Units = 2; Unit of Measure = 4.5mLs


  • Parathyroid hormone (PTH) IVD, calibrator
No Description
FUJIREBIO INC.
230190
Not in Commercial Distribution

  • 04987270230190 ()

  • Size Type = Tests per kit; Size Unit = 42; Unit of Measure = Tests


  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
235256
Not in Commercial Distribution

  • 04987270235256 ()

  • Size Type = Tests per Kit; Size Unit = 42; Unit of Measure = Tests


  • Progesterone IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
235218
Not in Commercial Distribution

  • 04987270235218 ()

  • Size Type = Tests Per Kit; Size Unit = 42; Unit of Measure = Tests


  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
235195
Not in Commercial Distribution

  • 04987270235195 ()

  • Size Type = Tests per Kit; Size Unit = 42; Unit of Measure = Tests


  • Prolactin IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
235171
In Commercial Distribution

  • 04987270235171 ()

  • Size Type = Tests Per Kit; Size Unit = 42; Unit of Measure = Tests


  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
235157
In Commercial Distribution

  • 04987270235157 ()

  • Size Type = Tests Per kit; Size Unit = 42; Unit of Measure = Tests


  • Soluble mesothelin-related peptide (SMRP) IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
235126
Not in Commercial Distribution

  • 04987270235126 ()

  • Size Type = Tests per kit; Size Unit = 42; Unit of Measure = Tests


  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
235102
In Commercial Distribution

  • 04987270235102 ()

  • Size Test =Tests per kit; Size Unit = 42; Unit of Measure = Tests


  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
235089
Not in Commercial Distribution

  • 04987270235089 ()

  • Size Type = Tests Per Kit; Size Unit = 42; Unit of Measure = Tests


  • Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA)
No Description
FUJIREBIO INC.
235058
In Commercial Distribution

  • 04987270235058 ()

  • Size Type = Tests Per Kit; Size Unit = 42; Unit of Measure = Tests


  • Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
235041
In Commercial Distribution

  • 04987270235041 ()

  • Size Type = Units per kit; Units = 2; Unit of Measure = 2mL
  • Size Type =Tests Per Kit; Size Unit = 42; Unit of Measure = Tests


  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
234945
In Commercial Distribution

  • 04987270234945 ()

  • Size Type =Units per Kit; Units = 14; Unit of Measure = 20mLs


  • Procalcitonin (PCT) IVD, control
No Description
FUJIREBIO INC.
234938
In Commercial Distribution

  • 04987270234938 ()

  • Size Type = Units per Kit; Units = 5; Unit of Measure = 10mLs


  • Procalcitonin (PCT) IVD, calibrator
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