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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 - 30014613332220

MRC-5 FROZEN SUSP.
DIAGNOSTIC HYBRIDS, INC.
51-00125C
In Commercial Distribution

  • 30014613332220 ()
51-00125C

  • 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 - 30014613332206

RHMK FLK 150 W/A
DIAGNOSTIC HYBRIDS, INC.
49-T150A
In Commercial Distribution

  • 30014613332206 ()
49-T150A

  • 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 - 30014613331421

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

  • 30014613331421 ()
16-309-150

  • Cell culture line IVD

Fresh Cells - 30014613331414

RMK FLKS/75 CM2
DIAGNOSTIC HYBRIDS, INC.
16-308-75
In Commercial Distribution

  • 30014613331414 ()
16-308-75

  • Cell culture line IVD

Fresh Cells - 30014613331407

RMK SV5/SV40 VIAL/SNAP CAP
DIAGNOSTIC HYBRIDS, INC.
15-309
In Commercial Distribution

  • 30014613331407 ()
15-309

  • Cell culture line IVD

Fresh Cells - 30014613331391

PMK VIAL/SNAP CAP
DIAGNOSTIC HYBRIDS, INC.
15-308
In Commercial Distribution

  • 30014613331391 ()
15-308

  • Cell culture line IVD

Fresh Cells - 30014613331384

RMK SV5/SV40 TUBE
DIAGNOSTIC HYBRIDS, INC.
14-309
In Commercial Distribution

  • 30014613331384 ()
14-309

  • Cell culture line IVD

Fresh Cells - 30014613331377

RMK TUBE
DIAGNOSTIC HYBRIDS, INC.
14-308
In Commercial Distribution

  • 30014613331377 ()
14-308

  • Cell culture line IVD

Fresh Cells - 30014613339571

Hela, MWP, 96W24F
DIAGNOSTIC HYBRIDS, INC.
72-9624C
In Commercial Distribution

  • 30014613339571 ()
72-9624C

  • Cell culture line IVD

Fresh Cells - 30014613339564

VERO SV WITHOUT CS
DIAGNOSTIC HYBRIDS, INC.
84-0101
In Commercial Distribution

  • 30014613339564 ()
84-0101

  • Cell culture line IVD

Fresh Cells - 30014613339281

Vero E6, MWP, 96W96F 90% conf
DIAGNOSTIC HYBRIDS, INC.
50-91-9696-90
In Commercial Distribution

  • 30014613339281 ()
50-91-9696-90

  • Cell culture line IVD

Fresh Cells - 30014613339274

Vero E6, MWP, 96W96F
DIAGNOSTIC HYBRIDS, INC.
91-9696
In Commercial Distribution

  • 30014613339274 ()
91-9696

  • Cell culture line IVD

Fresh Cells - 30014613338420

Super-BGMK FLK 225 SQ CM
DIAGNOSTIC HYBRIDS, INC.
70-T225
In Commercial Distribution

  • 30014613338420 ()
70-T225

  • Cell culture line IVD

Fresh Cells - 30014613338413

BGMK FLK 225 SQ CM
DIAGNOSTIC HYBRIDS, INC.
53-T225
In Commercial Distribution

  • 30014613338413 ()
53-T225

  • Cell culture line IVD

Fresh Cells - 30014613338307

RHMK FLK 225
DIAGNOSTIC HYBRIDS, INC.
49-T225DH
In Commercial Distribution

  • 30014613338307 ()
49-T225DH

  • Cell culture line IVD

Fresh Cells - 30014613338260

MDCK FLASK 225 SQ CM
DIAGNOSTIC HYBRIDS, INC.
83-T225DH
In Commercial Distribution

  • 30014613338260 ()
83-T225DH

  • Cell culture line IVD

Ready Cells - 30014613335849

RC R-MIX TOO SV FROZEN
DIAGNOSTIC HYBRIDS, INC.
F-97-0102-24
In Commercial Distribution

  • 30014613335849 ()
F-97-0102-24

  • Cell culture line IVD

Ready Cells - 30014613335832

RC R-MIX SV FROZEN CULT
DIAGNOSTIC HYBRIDS, INC.
F-96-0102-24
In Commercial Distribution

  • 30014613335832 ()
F-96-0102-24

  • Cell culture line IVD

Ready Cells - 30014613335825

SUPER E-MIX READYCELLS-24 VIAL
DIAGNOSTIC HYBRIDS, INC.
F-92-0102-24
In Commercial Distribution

  • 30014613335825 ()
F-92-0102-24

  • Cell culture line IVD

Ready Cells - 30014613335818

RC HS27 SV FROZEN CULT
DIAGNOSTIC HYBRIDS, INC.
F-87-0102-24
In Commercial Distribution

  • 30014613335818 ()
F-87-0102-24

  • Cell culture line IVD

Ready Cells - 30014613335801

RC MCCOY SV FROZEN CULT
DIAGNOSTIC HYBRIDS, INC.
F-54-0102-24
In Commercial Distribution

  • 30014613335801 ()
F-54-0102-24

  • Cell culture line IVD

Fresh Cells - 30014613335627

CITES RHMK FLK
DIAGNOSTIC HYBRIDS, INC.
C49-T150A
In Commercial Distribution

  • 30014613335627 ()
C49-T150A

  • Cell culture line IVD

Fresh Cells - 30014613335610

CITES KIDNEY RHESUS TUBE W/A
DIAGNOSTIC HYBRIDS, INC.
C49-0600A
In Commercial Distribution

  • 30014613335610 ()
C49-0600A

  • Cell culture line IVD

Fresh Cells - 30014613335603

CITES KIDNEY RHESUS SV W/C AN
DIAGNOSTIC HYBRIDS, INC.
C49-0102A
In Commercial Distribution

  • 30014613335603 ()
C49-0102A

  • Cell culture line IVD

Fresh Cells - 30014613335597

RHMK P1 FROZEN SUSP. CITES
DIAGNOSTIC HYBRIDS, INC.
C49-00010P
In Commercial Distribution

  • 30014613335597 ()
C49-00010P

  • Cell culture line IVD

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

Health o meter professional - 00851628008066

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

  • 00851628008066 ()


  • Stand-on floor scale, electronic

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

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

WIPEABLE GAIT BELT 70 INCH W/ PLASTIC BUCKLE ORANGE - 00733657216127

No Description
ALIMED, INC.
711023
In Commercial Distribution

  • 00733657216127 ()
2970008693

  • Movement-resistance gait rehabilitation device

WIPEABLE GAIT BELT 54 INCH W/ PLASTIC BUCKLE ORANGE - 00733657216110

No Description
ALIMED, INC.
711020
In Commercial Distribution

  • 00733657216110 ()
2970008691

  • Movement-resistance gait rehabilitation device
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