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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No Description
REMEL EUROPE LIMITED
R30858801
In Commercial Distribution

  • 05056080500966 ()


  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ Specimen Buffer Solution
BECTON, DICKINSON AND COMPANY
256391
Not in Commercial Distribution

  • 00382902563914 ()

  • Total Volume: 8 Milliliter
256391

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ Neisseria meningitidis Group B and E. coli K1 Test Kit
BECTON, DICKINSON AND COMPANY
255560
Not in Commercial Distribution

  • 00382902555605 ()
255560

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ Group B Strep Test
BECTON, DICKINSON AND COMPANY
255460
Not in Commercial Distribution

  • 00382902554608 ()
255460

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ Meningitis Combo Test Cards
BECTON, DICKINSON AND COMPANY
252480
Not in Commercial Distribution

  • 00382902524809 ()
252480

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ Meningitis Combo Test Kit
BECTON, DICKINSON AND COMPANY
252360
Not in Commercial Distribution

  • 00382902523604 ()
252360

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ H. influenzae type b Test
BECTON, DICKINSON AND COMPANY
252260
Not in Commercial Distribution

  • 00382902522607 ()
252260

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ S. pneumoniae Test
BECTON, DICKINSON AND COMPANY
251960
Not in Commercial Distribution

  • 00382902519607 ()
251960

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ Neisseria meningitidis Test Kit Groups A, C, Y and W135
BECTON, DICKINSON AND COMPANY
250160
Not in Commercial Distribution

  • 00382902501602 ()
250160

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
Kit BD MAX EXT Enteric Bacterial Panel
BECTON, DICKINSON AND COMPANY
443812
In Commercial Distribution

  • 00382904438128 ()
443812

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
Kit BD Max Enteric Bacterial Panel USA
Geneohm Sciences Canada Inc
443378
Not in Commercial Distribution

  • 00382904433789 ()
443378

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
Kit BD MAX Enteric Bacterial Panel
BECTON, DICKINSON AND COMPANY
442963
In Commercial Distribution

  • 00382904429638 ()
442963

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
Drill Sleeve Insert, MIS
Stryker GmbH
542116
In Commercial Distribution

  • 07613327625066 ()
542116

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Mkl Diagnostics AB
10-5593-12
In Commercial Distribution

  • 07350049850238 ()


  • Multiple meningitis-associated bacteria antigen IVD, control
No Description
Mkl Diagnostics AB
10-5592-12
In Commercial Distribution

  • 07350049850221 ()
10-5592-12

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ Meningitis Test Negative Control Reagent
BECTON, DICKINSON AND COMPANY
252350
Not in Commercial Distribution

  • 30382902523506 ()
  • 00382902523505 ()

  • Total Volume: 9 Milliliter
252350

  • Multiple meningitis-associated bacteria antigen IVD, control
No Description
Hologic, Inc.
PROGASTRO SSCS ASSAY
Not in Commercial Distribution

  • 15420045506350 ()
303278

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
M12016 - Escherichia coli Monovalent O Antiserum - Factor O111 - 2ml
MAST GROUP LIMITED
M12016
In Commercial Distribution

  • 15060392376260 ()
M12016

  • Escherichia coli multiple strain culture isolate antigen IVD, kit, agglutination
M12014 - Escherichia coli Monovalent O Antiserum - Factor O26 - 2ml
MAST GROUP LIMITED
M12014
In Commercial Distribution

  • 15060392376253 ()
M12014

  • Escherichia coli multiple strain culture isolate antigen IVD, kit, agglutination
Acetabular Liner, Hooded, 10 degree; Vitamin E UHMWPE; 32mm Inner Diameter, Size E
B-ONE ORTHO, CORP.
881201321E
In Commercial Distribution

  • 00843575102423 ()
881201321E

  • Non-constrained polyethylene acetabular liner
Acetabular Liner, Hooded, 10 degree; Vitamin E UHMWPE; 28mm Inner Diameter, Size E
B-ONE ORTHO, CORP.
881201281E
In Commercial Distribution

  • 00843575102393 ()
881201281E

  • Non-constrained polyethylene acetabular liner
Acetabular Liner, Neutral, 0 degree; Vitamin E UHMWPE; 32mm Inner Diameter, Size E
B-ONE ORTHO, CORP.
881200321E
In Commercial Distribution

  • 00843575102263 ()
881200321E

  • Non-constrained polyethylene acetabular liner
Acetabular Liner, Neutral, 0 degree; Vitamin E UHMWPE; 28mm Inner Diameter, Size E
B-ONE ORTHO, CORP.
881200281E
In Commercial Distribution

  • 00843575102232 ()
881200281E

  • Non-constrained polyethylene acetabular liner
Manhatten E&E Suturing Forceps, .7mm, 1x2 Teeth, 6mm Tying Platform, Flat, Titanium
AURORA SURGICAL, LLC
AS7-380T
In Commercial Distribution

  • 08175700125307 ()
AS7-380T

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Shiga Toxin Direct Test Cartridge with sample prep device.
GREAT BASIN SCIENTIFIC, INC.
GBSTEC-10
In Commercial Distribution

  • B178GBSTEC102 ()
  • B178GBSTEC100 ()
GBSTEC-10

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Biomet Orthopedics, LLC
31-301105
In Commercial Distribution

  • 00880304483842 ()

  • 60MM, SIZE E
31-301105

  • Orthopaedic broach
No Description
Biomet Orthopedics, LLC
31-311355
In Commercial Distribution

  • 00880304676008 ()

  • SIZE E 80MM
31-311355

  • Femoral stem prosthesis trial
No Description
Biomet Orthopedics, LLC
31-311335
In Commercial Distribution

  • 00880304675865 ()

  • SIZE E 70MM
31-311335

  • Femoral stem prosthesis trial
No Description
Biomet Orthopedics, LLC
31-311315
In Commercial Distribution

  • 00880304675728 ()

  • SIZE E 60MM
31-311315

  • Femoral stem prosthesis trial
No Description
Biomet Orthopedics, LLC
110017253
In Commercial Distribution

  • 00880304682276 ()

  • SIZE 36MM E
110017253

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
110017246
In Commercial Distribution

  • 00880304682207 ()

  • SIZE 32MM E
110017246

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
110017237
In Commercial Distribution

  • 00880304682146 ()

  • SIZE 28MM E
110017237

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
110010309
In Commercial Distribution

  • 00880304682047 ()

  • SIZE 36MM E
110010309

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
110024731
In Commercial Distribution

  • 00880304712874 ()

  • 42 mm E
110024731

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
110010300
In Commercial Distribution

  • 00880304700253 ()

  • SIZE 36MM E
110010300

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Zimmer, Inc.
42-5399-080-56
In Commercial Distribution

  • 00880304809383 ()

  • Size D/E
42-5399-080-56

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Solid Back Acetabular Shell
Howmedica Osteonics Corp.
540-11-52E
In Commercial Distribution

  • 04546540237835 ()

  • Outer Diameter: 52.0 Millimeter
  • Alpha Code: E
540-11-52E

  • Acetabular shell
Solid Back Acetabular Shell
Howmedica Osteonics Corp.
540-11-50E
In Commercial Distribution

  • 04546540237828 ()

  • Alpha Code: E
  • Outer Diameter: 50.0 Millimeter
540-11-50E

  • Acetabular shell
No Description
Zimmer, Inc.
SSI007031
In Commercial Distribution

  • 00889024648395 ()

  • 36mm +6 – E
SSI007031

  • Humeral head prosthesis trial, reusable
No Description
Zimmer, Inc.
SSI007026
In Commercial Distribution

  • 00889024648340 ()

  • 36mm +3 – E
SSI007026

  • Humeral head prosthesis trial, reusable
No Description
Zimmer, Inc.
SSI006748
In Commercial Distribution

  • 00889024645042 ()

  • 36mm +3 - E
SSI006748

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Acetabular Shell
Howmedica Osteonics Corp.
542-01-52E
In Commercial Distribution

  • 04546540081179 ()

  • Outer Diameter: 52.0 Millimeter
  • Alpha Code: E
542-01-52E

  • Acetabular shell
Acetabular Shell
Howmedica Osteonics Corp.
542-01-50E
In Commercial Distribution

  • 04546540081162 ()

  • Outer Diameter: 50.0 Millimeter
  • Alpha Code: E
542-01-50E

  • Acetabular shell
Acetabular Shell
Howmedica Osteonics Corp.
540-01-52E
In Commercial Distribution

  • 04546540080790 ()

  • Outer Diameter: 52.0 Millimeter
  • Alpha Code: E
540-01-52E

  • Acetabular shell
Acetabular Shell
Howmedica Osteonics Corp.
540-01-50E
In Commercial Distribution

  • 04546540080783 ()

  • Alpha Code: E
  • Outer Diameter: 50.0 Millimeter
540-01-50E

  • Acetabular shell
Hemispherical Acetabular Shell
Howmedica Osteonics Corp.
508-11-54E
In Commercial Distribution

  • 04546540432216 ()

  • Alpha Code: E
  • Outer Diameter: 54.0 Millimeter
508-11-54E

  • Acetabular shell
Hemispherical Acetabular Shell
Howmedica Osteonics Corp.
508-11-52E
In Commercial Distribution

  • 04546540432209 ()

  • Outer Diameter: 52.0 Millimeter
  • Alpha Code: E
508-11-52E

  • Acetabular shell
Hemispherical Acetabular Shell
Howmedica Osteonics Corp.
502-11-54E
In Commercial Distribution

  • 04546540432049 ()

  • Outer Diameter: 54.0 Millimeter
  • Alpha Code: E
502-11-54E

  • Acetabular shell
Hemispherical Acetabular Shell
Howmedica Osteonics Corp.
502-11-52E
In Commercial Distribution

  • 04546540432032 ()

  • Alpha Code: E
  • Outer Diameter: 52.0 Millimeter
502-11-52E

  • Acetabular shell
Hemispherical Acetabular Shell
Howmedica Osteonics Corp.
500-11-54E
In Commercial Distribution

  • 04546540431875 ()

  • Alpha Code: E
  • Outer Diameter: 54.0 Millimeter
500-11-54E

  • Acetabular shell
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