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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A549 TUBE LIGHT DENSITY
DIAGNOSTIC HYBRIDS, INC.
56-0600L
In Commercial Distribution

  • 30014613333135 ()
56-0600L

  • Cell culture line IVD
A549 TUBE
DIAGNOSTIC HYBRIDS, INC.
56-0600
In Commercial Distribution

  • 30014613333128 ()
56-0600

  • Cell culture line IVD
A549 SV/CS
DIAGNOSTIC HYBRIDS, INC.
56-0102
In Commercial Distribution

  • 30014613333111 ()
56-0102

  • Cell culture line IVD
A549 FROZEN SUSP. 50 MER
DIAGNOSTIC HYBRIDS, INC.
56-00050
In Commercial Distribution

  • 30014613333104 ()
56-00050

  • Cell culture line IVD
ELVIS MWP W24/24F W/CS
DIAGNOSTIC HYBRIDS, INC.
55-2424S
In Commercial Distribution

  • 30014613333098 ()
55-2424S

  • Cell culture line IVD
ELVIS MWP W24/24F
DIAGNOSTIC HYBRIDS, INC.
55-2424
In Commercial Distribution

  • 30014613333081 ()
55-2424

  • Cell culture line IVD
ELVIS MWP W24/18F WITH CS
DIAGNOSTIC HYBRIDS, INC.
55-2418S
In Commercial Distribution

  • 30014613333074 ()
55-2418S

  • Cell culture line IVD
ELVIS MWP W24/18F
DIAGNOSTIC HYBRIDS, INC.
55-2418
In Commercial Distribution

  • 30014613333067 ()
55-2418

  • Cell culture line IVD
ELVIS MWP W24/12F W/CS
DIAGNOSTIC HYBRIDS, INC.
55-2412S
In Commercial Distribution

  • 30014613333050 ()
55-2412S

  • Cell culture line IVD
ELVIS MWP W24/12F
DIAGNOSTIC HYBRIDS, INC.
55-2412
In Commercial Distribution

  • 30014613333043 ()
55-2412

  • Cell culture line IVD
ELVIS MWP W24/10F W/CS
DIAGNOSTIC HYBRIDS, INC.
55-2410S
In Commercial Distribution

  • 30014613333036 ()
55-2410S

  • Cell culture line IVD
ELVIS MWP W24/9F
DIAGNOSTIC HYBRIDS, INC.
55-2409
In Commercial Distribution

  • 30014613333029 ()
55-2409

  • Cell culture line IVD
ELVIS MWP W24/8F CUST FILL
DIAGNOSTIC HYBRIDS, INC.
55-2408DF
In Commercial Distribution

  • 30014613333012 ()
55-2408DF

  • Cell culture line IVD
ELVIS MWP W24/8F CUST
DIAGNOSTIC HYBRIDS, INC.
55-2408CB
In Commercial Distribution

  • 30014613333005 ()
55-2408CB

  • Cell culture line IVD
ELVIS MWP W24/6F W/CS
DIAGNOSTIC HYBRIDS, INC.
55-2406S
In Commercial Distribution

  • 30014613332992 ()
55-2406S

  • Cell culture line IVD
ELVIS MWP W24/6F CUST FILL
DIAGNOSTIC HYBRIDS, INC.
55-2406DE
In Commercial Distribution

  • 30014613332985 ()
55-2406DE

  • Cell culture line IVD
ELVIS MWP W24/6F
DIAGNOSTIC HYBRIDS, INC.
55-2406
In Commercial Distribution

  • 30014613332978 ()
55-2406

  • Cell culture line IVD
ELVIS SV/CS
DIAGNOSTIC HYBRIDS, INC.
55-0102
In Commercial Distribution

  • 30014613332961 ()
55-0102

  • Cell culture line IVD
Origin R Broach Size 18
ORTHOMEDFLEX LLC
112-44-1118
In Commercial Distribution

  • M7161124411180 ()


  • Orthopaedic broach
Origin R Broach Size 16
ORTHOMEDFLEX LLC
112-44-1116
In Commercial Distribution

  • M7161124411160 ()


  • Orthopaedic broach
Origin R Broach Size 15
ORTHOMEDFLEX LLC
112-44-1115
In Commercial Distribution

  • M7161124411150 ()


  • Orthopaedic broach
Origin R Broach Size 14
ORTHOMEDFLEX LLC
112-44-1114
In Commercial Distribution

  • M7161124411140 ()


  • Orthopaedic broach
Origin R Broach Size 13
ORTHOMEDFLEX LLC
112-44-1113
In Commercial Distribution

  • M7161124411130 ()


  • Orthopaedic broach
Origin R Broach Size 12
ORTHOMEDFLEX LLC
112-44-1112
In Commercial Distribution

  • M7161124411120 ()


  • Orthopaedic broach
Origin R Broach Size 11
ORTHOMEDFLEX LLC
112-44-1111
In Commercial Distribution

  • M7161124411110 ()


  • Orthopaedic broach
Origin R Broach Size 10
ORTHOMEDFLEX LLC
112-44-1110
In Commercial Distribution

  • M7161124411100 ()


  • Orthopaedic broach
Origin R Broach Size 9
ORTHOMEDFLEX LLC
112-44-1109
In Commercial Distribution

  • M7161124411090 ()


  • Orthopaedic broach
Origin R Broach Size 8
ORTHOMEDFLEX LLC
112-44-1108
In Commercial Distribution

  • M7161124411080 ()


  • Orthopaedic implant impactor, reusable
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
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
Origin Stem, Coxa Vara Size 10
PAXEON RECONSTRUCTION LLC
PR111-18-1004
In Commercial Distribution

  • 08177570200412 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 9
PAXEON RECONSTRUCTION LLC
PR111-18-0904
In Commercial Distribution

  • 08177570200375 ()


  • Coated hip femur prosthesis, modular
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
Eye Level Digital Scale, Origin USA
Pelstar, LLC
501KL
In Commercial Distribution

  • 00851628008066 ()


  • Stand-on floor scale, electronic
LEG-UP
THE HELPING HAND COMPANY (LEDBURY) LIMITED
LEG-UP YELLOW 26IN
In Commercial Distribution

  • 05050962080065 ()
HA0965

  • Movement-resistance gait rehabilitation device
LEG-UP
THE HELPING HAND COMPANY (LEDBURY) LIMITED
LEG-UP BLACK 26IN
In Commercial Distribution

  • 05050962023048 ()
HA0970

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
71243720
In Commercial Distribution

  • 00733657286090 ()
  • 00733657300321 ()
2970008985

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
3123
In Commercial Distribution

  • 00733657284690 ()
2970000595

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
713584
In Commercial Distribution

  • 00733657274523 ()
2970009328

  • Movement-resistance gait rehabilitation device
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