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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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MEDENTiKA - EMKA609109

Modelling cap set
MEDENTiKA GmbH
6-09-10
In Commercial Distribution

  • 04251574851741 ()
  • EMKA609109 ()

  • compatible with all systems
6-09-10

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609089

Modelling cap set
MEDENTiKA GmbH
6-09-08
In Commercial Distribution

  • 04251574851727 ()
  • EMKA609089 ()

  • compatible with all systems
6-09-08

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609069

Modelling cap set
MEDENTiKA GmbH
6-09-06
In Commercial Distribution

  • 04251574851703 ()
  • EMKA609069 ()

  • compatible with all systems
6-09-06

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609049

Modelling cap set
MEDENTiKA GmbH
6-09-04
In Commercial Distribution

  • 04251574847140 ()
  • EMKA609049 ()

  • compatible with all systems
6-09-04

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609029

Modelling cap set
MEDENTiKA GmbH
6-09-02
In Commercial Distribution

  • 04251574847126 ()
  • EMKA609029 ()

  • compatible with all systems
6-09-02

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA8515T9

Placement instrument laboratory implant
MEDENTiKA GmbH
8515 T
In Commercial Distribution

  • 04251574805898 ()
  • EMKA8515T9 ()

  • compatible with all systems
8515 T

  • Dental implant analog

MEDENTiKA - EMKA609409

Modelling cap set
MEDENTiKA GmbH
6-09-40
In Commercial Distribution

  • 04251574852519 ()
  • EMKA609409 ()

  • compatible with all systems
6-09-40

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609389

Modelling cap set
MEDENTiKA GmbH
6-09-38
In Commercial Distribution

  • 04251574852021 ()
  • EMKA609389 ()

  • compatible with all systems
6-09-38

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609329

Modelling cap set
MEDENTiKA GmbH
6-09-32
In Commercial Distribution

  • 04251574851963 ()
  • EMKA609329 ()

  • compatible with all systems
6-09-32

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609309

Modelling cap set
MEDENTiKA GmbH
6-09-30
In Commercial Distribution

  • 04251574851949 ()
  • EMKA609309 ()

  • compatible with all systems
6-09-30

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609299

Modelling cap set
MEDENTiKA GmbH
6-09-29
In Commercial Distribution

  • 04251574851932 ()
  • EMKA609299 ()

  • compatible with all systems
6-09-29

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609279

Modelling cap set
MEDENTiKA GmbH
6-09-27
In Commercial Distribution

  • 04251574851918 ()
  • EMKA609279 ()

  • compatible with all systems
6-09-27

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609249

Modelling cap set
MEDENTiKA GmbH
6-09-24
In Commercial Distribution

  • 04251574851888 ()
  • EMKA609249 ()

  • compatible with all systems
6-09-24

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609229

Modelling cap set
MEDENTiKA GmbH
6-09-22
In Commercial Distribution

  • 04251574851864 ()
  • EMKA609229 ()

  • compatible with all systems
6-09-22

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609209

Modelling cap set
MEDENTiKA GmbH
6-09-20
In Commercial Distribution

  • 04251574851840 ()
  • EMKA609209 ()

  • compatible with all systems
6-09-20

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609189

Modelling cap set
MEDENTiKA GmbH
6-09-18
In Commercial Distribution

  • 04251574851826 ()
  • EMKA609189 ()

  • compatible with all systems
6-09-18

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609169

Modelling cap set
MEDENTiKA GmbH
6-09-16
In Commercial Distribution

  • 04251574851802 ()
  • EMKA609169 ()

  • compatible with all systems
6-09-16

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609149

Modelling cap set
MEDENTiKA GmbH
6-09-14
In Commercial Distribution

  • 04251574851789 ()
  • EMKA609149 ()

  • compatible with all systems
6-09-14

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609129

Modelling cap set
MEDENTiKA GmbH
6-09-12
In Commercial Distribution

  • 04251574851765 ()
  • EMKA609129 ()

  • compatible with all systems
6-09-12

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609099

Modelling cap set
MEDENTiKA GmbH
6-09-09
In Commercial Distribution

  • 04251574851734 ()
  • EMKA609099 ()

  • compatible with all systems
6-09-09

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609079

Modelling cap set
MEDENTiKA GmbH
6-09-07
In Commercial Distribution

  • 04251574851710 ()
  • EMKA609079 ()

  • compatible with all systems
6-09-07

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609059

Modelling cap set
MEDENTiKA GmbH
6-09-05
In Commercial Distribution

  • 04251574847157 ()
  • EMKA609059 ()

  • compatible with all systems
6-09-05

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609039

Modelling cap set
MEDENTiKA GmbH
6-09-03
In Commercial Distribution

  • 04251574847133 ()
  • EMKA609039 ()

  • compatible with all systems
6-09-03

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKA609019

Modelling cap set
MEDENTiKA GmbH
6-09-01
In Commercial Distribution

  • 04251574847119 ()
  • EMKA609019 ()

  • compatible with all systems
6-09-01

  • Dental appliance fabrication material, thermoplastic

MEDENTiKA - EMKALX60SB9

Scanbody retention screw
MEDENTiKA GmbH
LX 60 SB
In Commercial Distribution

  • 04251574835338 ()
  • EMKALX60SB9 ()

  • compatible with Straumann / BLX
LX 60 SB

  • Dental implant suprastructure, permanent, preformed

MEDENTiKA - EMKALX14009

Scanbody
MEDENTiKA GmbH
LX 1400
In Commercial Distribution

  • 04251574806352 ()
  • EMKALX14009 ()

  • compatible with Straumann / BLX
LX 1400

  • Dental implant suprastructure, temporary, preformed, reusable

Altor Safety - G023622321

Altor Safety 4-Ply Surgical Mask (Model:62232) Outer Case of 2,000 Masks
Altor Safety LLC
62232
In Commercial Distribution

  • G023622321Z2 ()
  • G023622321 ()
62232

  • Surgical/medical face mask, non-antimicrobial, single-use

Altor Safety - G023622320

Altor Safety 4-Ply Surgical Mask (Model:62232) Inner Carton of 50 Masks
Altor Safety LLC
62232
In Commercial Distribution

  • G023622320 ()
62232

  • Surgical/medical face mask, non-antimicrobial, single-use

Altor Safety - G023622222

Altor Safety 3-Ply Surgical Mask (Model:62222) Outer Case of 2,000 Masks
Altor Safety LLC
62222
In Commercial Distribution

  • G023622222Z2 ()
  • G023622222 ()


  • Surgical/medical face mask, non-antimicrobial, single-use

Altor Safety - G023622221

Altor Safety 3-Ply Surgical Mask (Model:62222) Inner Carton of 50 Masks
Altor Safety LLC
62222
In Commercial Distribution

  • G023622221 ()


  • Surgical/medical face mask, non-antimicrobial, single-use

Medline - 10080196073320

BAG,BANDED,CIRCULAR,STERILE,20"
MEDLINE INDUSTRIES, INC.
DYNJE60020S
In Commercial Distribution

  • 10080196073320 ()
DYNJE60020S

  • Sterilization packaging, single-use

Emit II Plus Oxycodone Assay 30 mL Kit - 00630414028019

Emit II Plus Oxycodone Assay
Siemens Healthcare Diagnostics Inc.
10720808
In Commercial Distribution

  • 00630414028019 ()
9T039UL

  • Oxycodone IVD, kit, enzyme immunoassay (EIA)

Emit II Plus Oxycodone Assay 115 mL Kit - 00630414027937

Emit II Plus Oxycodone Assay
Siemens Healthcare Diagnostics Inc.
10720816
In Commercial Distribution

  • 00630414027937 ()
9T029UL

  • Oxycodone IVD, kit, enzyme immunoassay (EIA)

Emit II Plus Oxycodone Assay 1 L Kit - 00630414027920

Emit II Plus Oxycodone Assay
Siemens Healthcare Diagnostics Inc.
10720817
In Commercial Distribution

  • 00630414027920 ()
9T129UL

  • Oxycodone IVD, kit, enzyme immunoassay (EIA)

Lumipulse G SARS-CoV-2 Ag Immunoreaction Cartridges - 04987270260340

No Description
FUJIREBIO INC.
260340
In Commercial Distribution

  • 04987270260340 ()

  • Number of tests per kit: 42


  • SARS-CoV-2 antigen IVD, kit, chemiluminescent immunoassay

Lumipulse G Testosterone Immunoreaction Cartridges - 04987270235393

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

Lumipulse G TSH-III Immunoreaction Cartridges - 04987270235294

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

Lumipulse G LH Immunoreaction Cartridges - 04987270235270

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

Lumipulse G Progesterone-N Immunoreaction Cartridges - 04987270235256

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

Lumipulse G BHCG Immunoreaction Cartridges - 04987270235232

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

Lumipulse G FSH-N Immunoreaction Cartridges - 04987270235218

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

Lumipulse G Prolactin Immunoreaction Cartridges - 04987270235195

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

Lumipulse G E2-III Immunoreaction Cartridges - 04987270235171

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

Lumipulse G Mesothelin Immunoreaction Cartridges - 04987270235157

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

Lumipulse G CA 19-9-N Immunoreaction Cartridges - 04987270235126

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

Lumipulse G CA 15-3 Immunoreaction Cartridges - 04987270235102

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

Lumipulse G 25-OH Vitamin D Immunoreaction Cartridges - 04987270235089

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)

Lumipulse G BRAHMS PCT Immunoreaction Cartridges - 04987270235058

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

Lumipulse G TP-N Immunoreaction Cartridges Set - 04987270235041

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

Lumipulse BRAHMS PCT Controls - 04987270234945

No Description
FUJIREBIO INC.
234945
In Commercial Distribution

  • 04987270234945 ()

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


  • Procalcitonin (PCT) IVD, control
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