Company Name Brand Name GMDN Term 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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RHESUS II 96/24C
DIAGNOSTIC HYBRIDS, INC.
49-9624YC
In Commercial Distribution

  • 30014613332152 ()
49-9624YC

  • Cell culture line IVD
RHMK W48/48
DIAGNOSTIC HYBRIDS, INC.
49-4848
In Commercial Distribution

  • 30014613332145 ()
49-4848

  • Cell culture line IVD
RHMKII MW PLT 48W/12F
DIAGNOSTIC HYBRIDS, INC.
49-4812Y
In Commercial Distribution

  • 30014613332121 ()
49-4812Y

  • Cell culture line IVD
RHMK II MW PLATE 48-W/6-F
DIAGNOSTIC HYBRIDS, INC.
49-4806Y
In Commercial Distribution

  • 30014613332114 ()
49-4806Y

  • Cell culture line IVD
RHMK II RHES MONKEY 24W/24F
DIAGNOSTIC HYBRIDS, INC.
49-2424Y
In Commercial Distribution

  • 30014613332107 ()
49-2424Y

  • Cell culture line IVD
RHMK W24/24
DIAGNOSTIC HYBRIDS, INC.
49-2424A
In Commercial Distribution

  • 30014613332091 ()
49-2424A

  • Cell culture line IVD
RHMK II 24W/12F
DIAGNOSTIC HYBRIDS, INC.
49-2412Y
In Commercial Distribution

  • 30014613332077 ()
49-2412Y

  • Cell culture line IVD
MONKEY KIDNEY AFR.GREEN TUBE W
DIAGNOSTIC HYBRIDS, INC.
46-0600A
In Commercial Distribution

  • 30014613331889 ()
46-0600A

  • Cell culture line IVD
MONKEY KIDNEY AFRICAN GREEN TU
DIAGNOSTIC HYBRIDS, INC.
46-0600
In Commercial Distribution

  • 30014613331872 ()
46-0600

  • Cell culture line IVD
AGMK PRIMARY FREEZER VIAL
DIAGNOSTIC HYBRIDS, INC.
46-00020-DH
In Commercial Distribution

  • 30014613331865 ()
46-00020-DH

  • Cell culture line IVD
AGMK FROZEN SUSP.
DIAGNOSTIC HYBRIDS, INC.
46-00020
In Commercial Distribution

  • 30014613331858 ()
46-00020

  • Cell culture line IVD
MRHF FLASK 225 SQ CM
DIAGNOSTIC HYBRIDS, INC.
44-T225
In Commercial Distribution

  • 30014613331841 ()
44-T225

  • Cell culture line IVD
MRHF FLK 150 SQ CM
DIAGNOSTIC HYBRIDS, INC.
44-T150
In Commercial Distribution

  • 30014613331834 ()
44-T150

  • Cell culture line IVD
MRHF FLK 75 SQ CM
DIAGNOSTIC HYBRIDS, INC.
44-T075
In Commercial Distribution

  • 30014613331827 ()
44-T075

  • Cell culture line IVD
MRHF FLASK 25 SQ CM
DIAGNOSTIC HYBRIDS, INC.
44-T025
In Commercial Distribution

  • 30014613331810 ()
44-T025

  • Cell culture line IVD
MRHF PLATE W96 96F
DIAGNOSTIC HYBRIDS, INC.
44-9696
In Commercial Distribution

  • 30014613331803 ()
44-9696

  • Cell culture line IVD
MRHF PLATE W96 (EOC)
DIAGNOSTIC HYBRIDS, INC.
44-9648C
In Commercial Distribution

  • 30014613331797 ()
44-9648C

  • Cell culture line IVD
MRHF MW PLATE W96/12F
DIAGNOSTIC HYBRIDS, INC.
44-9612
In Commercial Distribution

  • 30014613331780 ()
44-9612

  • Cell culture line IVD
MRHF PLATE W24/24F
DIAGNOSTIC HYBRIDS, INC.
44-2424
In Commercial Distribution

  • 30014613331773 ()
44-2424

  • Cell culture line IVD
MRHF SHELL VIAL W/CS
DIAGNOSTIC HYBRIDS, INC.
44-0102
In Commercial Distribution

  • 30014613331759 ()
44-0102

  • Cell culture line IVD
MRHF FROZEN SUSP. 50 MER
DIAGNOSTIC HYBRIDS, INC.
44-00050
In Commercial Distribution

  • 30014613331742 ()
44-00050

  • Cell culture line IVD
HEL FLK 150 SQ CM
DIAGNOSTIC HYBRIDS, INC.
43-T150
In Commercial Distribution

  • 30014613331735 ()
43-T150

  • Cell culture line IVD
HEL FLK 75 SQ CM
DIAGNOSTIC HYBRIDS, INC.
43-T075
In Commercial Distribution

  • 30014613331728 ()
43-T075

  • Cell culture line IVD
HEL TUBE
DIAGNOSTIC HYBRIDS, INC.
43-0600
In Commercial Distribution

  • 30014613331711 ()
43-0600

  • Cell culture line IVD
NHFL 75 SQ CM LOW PASSAGE
DIAGNOSTIC HYBRIDS, INC.
42-T075C
In Commercial Distribution

  • 30014613331704 ()
42-T075C

  • Cell culture line IVD
NHFL 75 SQ CM FLK
DIAGNOSTIC HYBRIDS, INC.
42-T075
In Commercial Distribution

  • 30014613331698 ()
42-T075

  • Cell culture line IVD
Gamma Lewis Blood Group Substance is intended for use in assistance in the identification of unexpected blood group antibodies by neutralizing anti-Lea and anti-Leb activity in serum or plasma. Gamma Lewis Blood Group Substance is a standardized solution of human Lea and Leb blood group substances in phosphate-buffered saline. This package configuration is one (1) vial of 2 mL volume.
IMMUCOR, INC.
0007702
In Commercial Distribution

  • 10888234000853 ()
0007702

  • Immunoglobulin removal reagent IVD
Gamma P1 Blood Group Substance is intended for use in assistance in the identification of unexpected blood group antibodies by neutralizing anti-P1 activity in serum or plasma. Gamma P1 Blood Group Substance is a standardized solution of avian P1 blood group substance in phosphate-buffered saline. This package configuration is one (1) vial of 2 mL volume.
IMMUCOR, INC.
0007700
In Commercial Distribution

  • 10888234000846 ()
0007700

  • Immunoglobulin removal reagent IVD
Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0002-02
In Commercial Distribution

  • 03760178394857 ()


  • General internal orthopaedic fixation system implantation kit
Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0002
In Commercial Distribution

  • 03760178394840 ()


  • General internal orthopaedic fixation system implantation kit
Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0001
In Commercial Distribution

  • 03760178394833 ()


  • General internal orthopaedic fixation system implantation kit
Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-SQA-0025
In Commercial Distribution

  • 03760178394826 ()


  • General internal orthopaedic fixation system implantation kit
Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-CPL-0002
In Commercial Distribution

  • 03760178394802 ()


  • General internal orthopaedic fixation system implantation kit
Origin Stem, Coxa Vara Size 18
PAXEON RECONSTRUCTION LLC
PR111-18-1804
In Commercial Distribution

  • 08177570200696 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 16
PAXEON RECONSTRUCTION LLC
PR111-18-1604
In Commercial Distribution

  • 08177570200658 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 15
PAXEON RECONSTRUCTION LLC
PR111-18-1504
In Commercial Distribution

  • 08177570200610 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 14
PAXEON RECONSTRUCTION LLC
PR111-18-1404
In Commercial Distribution

  • 08177570200573 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 13
PAXEON RECONSTRUCTION LLC
PR111-18-1304
In Commercial Distribution

  • 08177570200535 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 12
PAXEON RECONSTRUCTION LLC
PR111-18-1204
In Commercial Distribution

  • 08177570200498 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 11
PAXEON RECONSTRUCTION LLC
PR111-18-1104
In Commercial Distribution

  • 08177570200450 ()


  • Coated hip femur prosthesis, modular
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