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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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CARDINAL HEALTH - 10197106607275

ORTHO CLINIC MSR PACK
Cardinal Health 200, LLC
SOP73COKS3
In Commercial Distribution

  • 50197106607273 ()
  • 10197106607275 ()
SOP73COKS3

  • Orthopaedic surgical procedure kit, medicated

CARDINAL HEALTH - 10197106896860

ORTHO CLINIC MSR PACK
Cardinal Health 200, LLC
SOP73COKS5
In Commercial Distribution

  • 50197106896868 ()
  • 10197106896860 ()
SOP73COKS5

  • Orthopaedic surgical procedure kit, medicated

CARDINAL HEALTH - 10197106632604

ORTHO CLINIC MSR PACK
Cardinal Health 200, LLC
SOP73COKS4
In Commercial Distribution

  • 50197106632602 ()
  • 10197106632604 ()
SOP73COKS4

  • Orthopaedic surgical procedure kit, medicated

CARDINAL HEALTH - 10195594396473

ORTHO CLINIC MSR PACK
Cardinal Health 200, LLC
SOP73COKSA
In Commercial Distribution

  • 50195594396471 ()
  • 10195594396473 ()
SOP73COKSA

  • Orthopaedic surgical procedure kit, medicated

CARDINAL HEALTH - 10195594628154

ORTHO CLINIC MSR PACK
Cardinal Health 200, LLC
SOP73COKS1
In Commercial Distribution

  • 50195594628152 ()
  • 10195594628154 ()
SOP73COKS1

  • Orthopaedic surgical procedure kit, medicated

N/A - 00681490902922

INSTRUMENT 8691015 CRSLK MSR TOOL CRD17
MEDTRONIC SOFAMOR DANEK, INC.
8691015
In Commercial Distribution

  • 00681490902922 ()


  • Bone-screw internal spinal fixation system connector

N/A - 00681490902908

INSTRUMENT 8691013 CRSLK MSR TOOL CRD13
MEDTRONIC SOFAMOR DANEK, INC.
8691013
In Commercial Distribution

  • 00681490902908 ()


  • Bone-screw internal spinal fixation system connector

N/A - 00681490902892

INSTRUMENT 8691012 CRSLK MSR TOOL CRD11
MEDTRONIC SOFAMOR DANEK, INC.
8691012
In Commercial Distribution

  • 00681490902892 ()


  • Bone-screw internal spinal fixation system connector

Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA - 00404847451894

The Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 2 in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-5189
Not in Commercial Distribution

  • 00404847451894 ()
EIA-5189

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA - 00404847451887

The Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 1 in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-5188
Not in Commercial Distribution

  • 00404847451887 ()
EIA-5188

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA - 00840239051899

The Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 2 in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-5189
In Commercial Distribution

  • 00840239051899 ()
EIA-5189

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA - 00840239051882

The Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 1 in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-5188
In Commercial Distribution

  • 00840239051882 ()
EIA-5188

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

CHORUS Q FEVER PHASE II IgG - 08033891322083

No Description
DIESSE DIAGNOSTICA SENESE SPA
81171
In Commercial Distribution

  • 08033891322083 ()
81171

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA - 04048474051896

The Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 2 in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-5189
In Commercial Distribution

  • 04048474051896 ()
EIA-5189

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA - 04048474051889

The Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 1 in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-5188
In Commercial Distribution

  • 04048474051889 ()
EIA-5188

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

NovaLisa Coxiella burnetii (Q-Fever) Phase 2 IgG - ENTICOX2G0600

The Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 2 in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
COX2G060
In Commercial Distribution

  • ENTICOX2G0600 ()
COX2G0600

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

NovaLisa Coxiella burnetii (Q-Fever) Phase 1 IgG - ENTICOX1G0600

The Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 1 in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
COX1G060
In Commercial Distribution

  • ENTICOX1G0600 ()
COX1G0600

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

C. burnetii 12 Well 10 pk - 00813545026073

No Description
SCIMEDX CORPORATION
I-QFB01X
In Commercial Distribution

  • 00813545026073 ()
I-QFB01X

  • Coxiella burnetii total antibody IVD, kit, fluorescent immunoassay

JBAIDS - 00851458005013

JBAIDS IVD Q Fever Detection Kit
BIOFIRE DEFENSE, LLC
JRPD-ASY-0016
Not in Commercial Distribution

  • 00851458005013 ()
JRPD-ASY-0016

  • Coxiella burnetii nucleic acid IVD, kit, nucleic acid technique (NAT)

N/A - 00681490902939

INSTRUMENT 8691016 CRSLK MSR TL CRD 19MM
MEDTRONIC SOFAMOR DANEK, INC.
8691016
In Commercial Distribution

  • 00681490902939 ()


  • Bone-screw internal spinal fixation system connector

N/A - 00681490902915

INSTRUMENT 8691014 CRSLK MSR TOOL CRD 15
MEDTRONIC SOFAMOR DANEK, INC.
8691014
In Commercial Distribution

  • 00681490902915 ()


  • Bone-screw internal spinal fixation system connector

CytoCell - 05055844905948

Del(20q) Deletion FISH Probe Kit
CYTOCELL LIMITED
USA-LPH020
In Commercial Distribution

USA-LPH020

  • Myelodysplastic syndrome (MDS) IVD, probe

Cytocell Aquarius - 05055844901575

Del(20q) Deletion FISH Probe Kit
CYTOCELL LIMITED
USA-LPH020
In Commercial Distribution

  • 05055844901575 ()
USA-LPH020

  • Myelodysplastic syndrome (MDS) IVD, probe

CytoCell - 05055844923850

Del(20q) Deletion FISH Probe Kit (IVD (USA))
CYTOCELL LIMITED
USA-LPH020
In Commercial Distribution



  • Myelodysplastic syndrome (MDS) IVD, probe

Synergetics - 10841305111896

Universal Viscous Fluid Control Pack
SYNERGETICS USA, INC.
BL7600
In Commercial Distribution

  • 20841305111909 ()
  • 10841305111896 ()
BL7600

  • Surgical irrigation tubing set, single-use

Bausch + Lomb - 00757770411160

SILICONE TUBE .132"x.183"x50FT
Bausch & Lomb Incorporated
N5941 11A
In Commercial Distribution

  • 00757770411160 ()
N5941 11A

  • Ophthalmic irrigation/infusion/aspiration tubing, single-use

Bausch + Lomb - 00757770409549

SILICONE TUBE .250"x.375"x10FT
Bausch & Lomb Incorporated
N5941 14
In Commercial Distribution

  • 00757770409549 ()
N5941 14

  • Ophthalmic irrigation/infusion/aspiration tubing, single-use

Bausch + Lomb - 00757770402083

SILICONE TUBE .062"x.125"x50FT
Bausch & Lomb Incorporated
N5941 8A
In Commercial Distribution

  • 00757770402083 ()
N5941 8A

  • Ophthalmic irrigation/infusion/aspiration tubing, single-use

Bausch + Lomb - 00757770436101

SILICONE TUBE .012"x.025"x10FT
Bausch & Lomb Incorporated
N5941 1
In Commercial Distribution

  • 00757770436101 ()
N5941 1

  • Ophthalmic irrigation/infusion/aspiration tubing, single-use

Bausch + Lomb - 00757770433353

SILICONE TUBE .104"x.192"x10FT
Bausch & Lomb Incorporated
N5941 10
In Commercial Distribution

  • 00757770433353 ()
N5941 10

  • Ophthalmic irrigation/infusion/aspiration tubing, single-use

Bausch + Lomb - 00757770431830

SILICONE TUBE .030"x.065"x50FT
Bausch & Lomb Incorporated
N5941 4A
In Commercial Distribution

  • 00757770431830 ()
N5941 4A

  • Ophthalmic irrigation/infusion/aspiration tubing, single-use

Bausch + Lomb - 00757770431595

SILICONE TUBE .250"x.375"x50FT
Bausch & Lomb Incorporated
N5941 14A
In Commercial Distribution

  • 00757770431595 ()
N5941 14A

  • Ophthalmic irrigation/infusion/aspiration tubing, single-use

Bausch + Lomb - 00757770429394

SILICONE TUBE .020"x.037"x50FT
Bausch & Lomb Incorporated
N5941 2A
In Commercial Distribution

  • 00757770429394 ()
N5941 2A

  • Ophthalmic irrigation/infusion/aspiration tubing, single-use

Bausch + Lomb - 00757770428229

SILICONE TUBE .040"x.085"x10FT
Bausch & Lomb Incorporated
N5941 5
In Commercial Distribution

  • 00757770428229 ()
N5941 5

  • Ophthalmic irrigation/infusion/aspiration tubing, single-use

Bausch + Lomb - 00757770428144

SILICONE TUBE .040"x.085"x50FT
Bausch & Lomb Incorporated
N5941 5A
In Commercial Distribution

  • 00757770428144 ()
N5941 5A

  • Ophthalmic irrigation/infusion/aspiration tubing, single-use

Bausch + Lomb - 00757770427130

SILICONE TUBE .030"x.065"x10FT
Bausch & Lomb Incorporated
N5941 4
In Commercial Distribution

  • 00757770427130 ()
N5941 4

  • Ophthalmic irrigation/infusion/aspiration tubing, single-use

Bausch + Lomb - 00757770422159

SILICONE TUBE .188"x.312"x50FT
Bausch & Lomb Incorporated
N5941 13A
In Commercial Distribution

  • 00757770422159 ()
N5941 13A

  • Ophthalmic irrigation/infusion/aspiration tubing, single-use

Bausch + Lomb - 00757770422005

SILICONE TUBE .012"x.025"x50FT
Bausch & Lomb Incorporated
N5941 1A
In Commercial Distribution

  • 00757770422005 ()
N5941 1A

  • Ophthalmic irrigation/infusion/aspiration tubing, single-use

Bausch + Lomb - 00757770417216

SILICONE TUBE .125"x.250"x10FT
Bausch & Lomb Incorporated
N5941 12
In Commercial Distribution

  • 00757770417216 ()
N5941 12

  • Ophthalmic irrigation/infusion/aspiration tubing, single-use

Bausch + Lomb - 00757770416127

SILICONE TUBE .125"x.250"x50FT
Bausch & Lomb Incorporated
N5941 12A
In Commercial Distribution

  • 00757770416127 ()
N5941 12A

  • Ophthalmic irrigation/infusion/aspiration tubing, single-use
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