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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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Fresh Cells - 30014613332572

BGMK SV/CS
DIAGNOSTIC HYBRIDS, INC.
53-0102
In Commercial Distribution

  • 30014613332572 ()
53-0102

  • Cell culture line IVD

Fresh Cells - 30014613332565

BGMK FROZEN SUSP. 50 MER
DIAGNOSTIC HYBRIDS, INC.
53-00050
In Commercial Distribution

  • 30014613332565 ()
53-00050

  • Cell culture line IVD

Fresh Cells - 30014613332534

CV1 W24/24
DIAGNOSTIC HYBRIDS, INC.
52-2424
In Commercial Distribution

  • 30014613332534 ()
52-2424

  • Cell culture line IVD

Fresh Cells - 30014613332275

MRC-5 W24/06
DIAGNOSTIC HYBRIDS, INC.
51-2406
In Commercial Distribution

  • 30014613332275 ()
51-2406

  • Cell culture line IVD

Fresh Cells - 30014613332268

MRC-5 CELLS TUBE CULT 13MM
DIAGNOSTIC HYBRIDS, INC.
51-0620EU
In Commercial Distribution

  • 30014613332268 ()
51-0620EU

  • Cell culture line IVD

Fresh Cells - 30014613332251

MRC-5 CELLS TUBE CULT
DIAGNOSTIC HYBRIDS, INC.
51-0600
In Commercial Distribution

  • 30014613332251 ()
51-0600

  • Cell culture line IVD

Fresh Cells - 30014613332237

MRC-5 SV WITHOUT CS
DIAGNOSTIC HYBRIDS, INC.
51-0101
In Commercial Distribution

  • 30014613332237 ()
51-0101

  • Cell culture line IVD

Fresh Cells - 30014613332213

MRC-5 FROZEN SUSP. 50-MER
DIAGNOSTIC HYBRIDS, INC.
51-00050
In Commercial Distribution

  • 30014613332213 ()
51-00050

  • Cell culture line IVD

Fresh Cells - 30014613332190

RHMK FLK 150
DIAGNOSTIC HYBRIDS, INC.
49-T150
In Commercial Distribution

  • 30014613332190 ()
49-T150

  • Cell culture line IVD

Fresh Cells - 30014613332183

RHMK FLK 75 W/A
DIAGNOSTIC HYBRIDS, INC.
49-T075A
In Commercial Distribution

  • 30014613332183 ()
49-T075A

  • Cell culture line IVD

Fresh Cells - 30014613332169

MONKEY KIDNEY RHESUS FLASK 25
DIAGNOSTIC HYBRIDS, INC.
49-T025A
In Commercial Distribution

  • 30014613332169 ()
49-T025A

  • Cell culture line IVD

Fresh Cells - 30014613332152

RHESUS II 96/24C
DIAGNOSTIC HYBRIDS, INC.
49-9624YC
In Commercial Distribution

  • 30014613332152 ()
49-9624YC

  • Cell culture line IVD

Fresh Cells - 30014613332145

RHMK W48/48
DIAGNOSTIC HYBRIDS, INC.
49-4848
In Commercial Distribution

  • 30014613332145 ()
49-4848

  • Cell culture line IVD

Fresh Cells - 30014613332138

RHMK II MWP 48/18
DIAGNOSTIC HYBRIDS, INC.
49-4818Y
In Commercial Distribution

  • 30014613332138 ()
49-4818Y

  • Cell culture line IVD

Fresh Cells - 30014613332121

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

  • 30014613332121 ()
49-4812Y

  • Cell culture line IVD

Fresh Cells - 30014613332114

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

  • 30014613332114 ()
49-4806Y

  • Cell culture line IVD

Fresh Cells - 30014613332107

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

  • 30014613332107 ()
49-2424Y

  • Cell culture line IVD

Fresh Cells - 30014613332091

RHMK W24/24
DIAGNOSTIC HYBRIDS, INC.
49-2424A
In Commercial Distribution

  • 30014613332091 ()
49-2424A

  • Cell culture line IVD

Fresh Cells - 30014613332084

RHMK W24/24
DIAGNOSTIC HYBRIDS, INC.
49-2424
In Commercial Distribution

  • 30014613332084 ()
49-2424

  • Cell culture line IVD

Fresh Cells - 30014613332077

RHMK II 24W/12F
DIAGNOSTIC HYBRIDS, INC.
49-2412Y
In Commercial Distribution

  • 30014613332077 ()
49-2412Y

  • Cell culture line IVD

Fresh Cells - 30014613331735

HEL FLK 150 SQ CM
DIAGNOSTIC HYBRIDS, INC.
43-T150
In Commercial Distribution

  • 30014613331735 ()
43-T150

  • Cell culture line IVD

Fresh Cells - 30014613331728

HEL FLK 75 SQ CM
DIAGNOSTIC HYBRIDS, INC.
43-T075
In Commercial Distribution

  • 30014613331728 ()
43-T075

  • Cell culture line IVD

Fresh Cells - 30014613331711

HEL TUBE
DIAGNOSTIC HYBRIDS, INC.
43-0600
In Commercial Distribution

  • 30014613331711 ()
43-0600

  • Cell culture line IVD

Fresh Cells - 30014613331704

NHFL 75 SQ CM LOW PASSAGE
DIAGNOSTIC HYBRIDS, INC.
42-T075C
In Commercial Distribution

  • 30014613331704 ()
42-T075C

  • Cell culture line IVD

Fresh Cells - 30014613331698

NHFL 75 SQ CM FLK
DIAGNOSTIC HYBRIDS, INC.
42-T075
In Commercial Distribution

  • 30014613331698 ()
42-T075

  • Cell culture line IVD

Fresh Cells - 30014613331445

RMK SV5/SV40 PLATE 24-WELL
DIAGNOSTIC HYBRIDS, INC.
18-309-24
In Commercial Distribution

  • 30014613331445 ()
18-309-24

  • Cell culture line IVD

Fresh Cells - 30014613331438

RMK SV5/SV40 FLK/75 CM2
DIAGNOSTIC HYBRIDS, INC.
16-309-75
In Commercial Distribution

  • 30014613331438 ()
16-309-75

  • Cell culture line IVD

Fresh Cells - 30014613331421

RMK SV5/SV40 FLK/150 CM2
DIAGNOSTIC HYBRIDS, INC.
16-309-150
In Commercial Distribution

  • 30014613331421 ()
16-309-150

  • Cell culture line IVD

Health o meter professional - 00851628008066

Eye Level Digital Scale, Origin USA
Pelstar, LLC
501KL
In Commercial Distribution

  • 00851628008066 ()


  • Stand-on floor scale, electronic

Orthopaedic & Spine Development (OSD) - 03760178394857

Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0002-02
In Commercial Distribution

  • 03760178394857 ()


  • General internal orthopaedic fixation system implantation kit

Orthopaedic & Spine Development (OSD) - 03760178394840

Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0002
In Commercial Distribution

  • 03760178394840 ()


  • General internal orthopaedic fixation system implantation kit

Orthopaedic & Spine Development (OSD) - 03760178394833

Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0001
In Commercial Distribution

  • 03760178394833 ()


  • General internal orthopaedic fixation system implantation kit

Orthopaedic & Spine Development (OSD) - 03760178394826

Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-SQA-0025
In Commercial Distribution

  • 03760178394826 ()


  • General internal orthopaedic fixation system implantation kit

Orthopaedic & Spine Development (OSD) - 03760178394802

Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-CPL-0002
In Commercial Distribution

  • 03760178394802 ()


  • General internal orthopaedic fixation system implantation kit

Paxeon Origin Coxa Vara Hip Stem - 08177570200696

Origin Stem, Coxa Vara Size 18
PAXEON RECONSTRUCTION LLC
PR111-18-1804
In Commercial Distribution

  • 08177570200696 ()


  • Coated hip femur prosthesis, modular

Paxeon Origin Coxa Vara Hip Stem - 08177570200658

Origin Stem, Coxa Vara Size 16
PAXEON RECONSTRUCTION LLC
PR111-18-1604
In Commercial Distribution

  • 08177570200658 ()


  • Coated hip femur prosthesis, modular

Paxeon Origin Coxa Vara Hip Stem - 08177570200610

Origin Stem, Coxa Vara Size 15
PAXEON RECONSTRUCTION LLC
PR111-18-1504
In Commercial Distribution

  • 08177570200610 ()


  • Coated hip femur prosthesis, modular

Paxeon Origin Coxa Vara Hip Stem - 08177570200573

Origin Stem, Coxa Vara Size 14
PAXEON RECONSTRUCTION LLC
PR111-18-1404
In Commercial Distribution

  • 08177570200573 ()


  • Coated hip femur prosthesis, modular

Paxeon Origin Coxa Vara Hip Stem - 08177570200535

Origin Stem, Coxa Vara Size 13
PAXEON RECONSTRUCTION LLC
PR111-18-1304
In Commercial Distribution

  • 08177570200535 ()


  • Coated hip femur prosthesis, modular

Paxeon Origin Coxa Vara Hip Stem - 08177570200498

Origin Stem, Coxa Vara Size 12
PAXEON RECONSTRUCTION LLC
PR111-18-1204
In Commercial Distribution

  • 08177570200498 ()


  • Coated hip femur prosthesis, modular

Paxeon Origin Coxa Vara Hip Stem - 08177570200450

Origin Stem, Coxa Vara Size 11
PAXEON RECONSTRUCTION LLC
PR111-18-1104
In Commercial Distribution

  • 08177570200450 ()


  • Coated hip femur prosthesis, modular

Paxeon Origin Coxa Vara Hip Stem - 08177570200412

Origin Stem, Coxa Vara Size 10
PAXEON RECONSTRUCTION LLC
PR111-18-1004
In Commercial Distribution

  • 08177570200412 ()


  • Coated hip femur prosthesis, modular

Paxeon Origin Coxa Vara Hip Stem - 08177570200375

Origin Stem, Coxa Vara Size 9
PAXEON RECONSTRUCTION LLC
PR111-18-0904
In Commercial Distribution

  • 08177570200375 ()


  • Coated hip femur prosthesis, modular

Gamma Lewis Blood Group Substance - 10888234000853

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 - 10888234000846

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

LEG-UP - 05050962080065

LEG-UP
THE HELPING HAND COMPANY (LEDBURY) LIMITED
LEG-UP YELLOW 26IN
In Commercial Distribution

  • 05050962080065 ()
HA0965

  • Movement-resistance gait rehabilitation device

LEG-UP - 05050962023048

LEG-UP
THE HELPING HAND COMPANY (LEDBURY) LIMITED
LEG-UP BLACK 26IN
In Commercial Distribution

  • 05050962023048 ()
HA0970

  • Movement-resistance gait rehabilitation device

WIPEABLE GAIT BELT 96" W/ PLASTIC BUCKLE YELLOW - 00733657216172

No Description
ALIMED, INC.
711779
In Commercial Distribution

  • 00733657216172 ()
2970008801

  • Movement-resistance gait rehabilitation device

WIPEABLE GAIT BELT 70 INCH W/ PLASTIC BUCKLE BLUE - 00733657216141

No Description
ALIMED, INC.
711029
In Commercial Distribution

  • 00733657216141 ()
2970008697

  • Movement-resistance gait rehabilitation device

WIPEABLE GAIT BELT 54 INCH W/ PLASTIC BUCKLE BLUE - 00733657216134

No Description
ALIMED, INC.
711026
In Commercial Distribution

  • 00733657216134 ()
2970008694

  • Movement-resistance gait rehabilitation device
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