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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 - 30014613332855

MCCOY W24/24 WITH CS
DIAGNOSTIC HYBRIDS, INC.
54-2424S
In Commercial Distribution

  • 30014613332855 ()
54-2424S

  • Cell culture line IVD

Fresh Cells - 30014613332848

MCCOY W24/24
DIAGNOSTIC HYBRIDS, INC.
54-2424
In Commercial Distribution

  • 30014613332848 ()
54-2424

  • Cell culture line IVD

Fresh Cells - 30014613332831

MCCOY W24/18
DIAGNOSTIC HYBRIDS, INC.
54-2418
In Commercial Distribution

  • 30014613332831 ()
54-2418

  • Cell culture line IVD

Fresh Cells - 30014613332824

MCCOY W24/12 WITH CS
DIAGNOSTIC HYBRIDS, INC.
54-2412S
In Commercial Distribution

  • 30014613332824 ()
54-2412S

  • Cell culture line IVD

Fresh Cells - 30014613332817

MCCOY W24/12
DIAGNOSTIC HYBRIDS, INC.
54-2412
In Commercial Distribution

  • 30014613332817 ()
54-2412

  • Cell culture line IVD

Fresh Cells - 30014613332800

MCCOY PLATES
DIAGNOSTIC HYBRIDS, INC.
54-2406
In Commercial Distribution

  • 30014613332800 ()
54-2406

  • Cell culture line IVD

Fresh Cells - 30014613332794

MCCOY SV/CS WITH LIGHT DENSITY
DIAGNOSTIC HYBRIDS, INC.
54-0102L
In Commercial Distribution

  • 30014613332794 ()
54-0102L

  • Cell culture line IVD

Fresh Cells - 30014613332787

MCCOY SV/CS
DIAGNOSTIC HYBRIDS, INC.
54-0102
In Commercial Distribution

  • 30014613332787 ()
54-0102

  • Cell culture line IVD

Fresh Cells - 30014613332770

MCCOY FROZEN SUSP. 50 MER
DIAGNOSTIC HYBRIDS, INC.
54-00050C
In Commercial Distribution

  • 30014613332770 ()
54-00050C

  • Cell culture line IVD

Fresh Cells - 30014613332763

MCCOY FROZEN SUSP. 50 MER
DIAGNOSTIC HYBRIDS, INC.
54-00050
In Commercial Distribution

  • 30014613332763 ()
54-00050

  • Cell culture line IVD

Fresh Cells - 30014613332756

BGMK FLK 150 SQ CM
DIAGNOSTIC HYBRIDS, INC.
53-T150
In Commercial Distribution

  • 30014613332756 ()
53-T150

  • Cell culture line IVD

Fresh Cells - 30014613332749

BGMK FLK 75 SQ CM LIGHT
DIAGNOSTIC HYBRIDS, INC.
53-T075C
In Commercial Distribution

  • 30014613332749 ()
53-T075C

  • Cell culture line IVD

Fresh Cells - 30014613332732

BGMK FLK 75 SQ CM
DIAGNOSTIC HYBRIDS, INC.
53-T075
In Commercial Distribution

  • 30014613332732 ()
53-T075

  • Cell culture line IVD

Fresh Cells - 30014613332725

BGMK FLASK 25 SQ CM 50% CONFLU
DIAGNOSTIC HYBRIDS, INC.
53-T025-50
In Commercial Distribution

  • 30014613332725 ()
53-T025-50

  • Cell culture line IVD

Fresh Cells - 30014613332718

BGMK FLASK 25 SQ CM
DIAGNOSTIC HYBRIDS, INC.
53-T025
In Commercial Distribution

  • 30014613332718 ()
53-T025

  • Cell culture line IVD

Fresh Cells - 30014613332701

BGMK W96/96
DIAGNOSTIC HYBRIDS, INC.
53-9696
In Commercial Distribution

  • 30014613332701 ()
53-9696

  • 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

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

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

THIN GAIT BELT 54 INCH 20/CA - 00733657286090

No Description
ALIMED, INC.
71243720
In Commercial Distribution

  • 00733657286090 ()
  • 00733657300321 ()
2970008985

  • Movement-resistance gait rehabilitation device

BELT WALKER PEDIATRIC (10) - 00733657284690

No Description
ALIMED, INC.
3123
In Commercial Distribution

  • 00733657284690 ()
2970000595

  • Movement-resistance gait rehabilitation device

WIPEABLE GAIT BELT 70IN W/ PLASTIC BUCKLE YELLOW - 00733657274523

No Description
ALIMED, INC.
713584
In Commercial Distribution

  • 00733657274523 ()
2970009328

  • Movement-resistance gait rehabilitation device

WIPEABLE GAIT BELT 54IN W/ PLASTIC BUCKLE YELLOW - 00733657274516

No Description
ALIMED, INC.
713583
In Commercial Distribution

  • 00733657274516 ()
2970009326

  • Movement-resistance gait rehabilitation device

BELT GAIT WITH ODOR CONTROL 54IN 20/CS - 00733657242645

No Description
ALIMED, INC.
7025720
In Commercial Distribution

  • 00733657242645 ()
  • 00733657299533 ()
2970008131

  • Movement-resistance gait rehabilitation device

THIN GAIT BELT 54 INCH - 00733657232141

No Description
ALIMED, INC.
712437
In Commercial Distribution

  • 00733657232141 ()
2970008984

  • Movement-resistance gait rehabilitation device

GAIT BELT DISP BLUE 70 IN PLASTIC BUCKLE CS 36 - 00733657230635

No Description
ALIMED, INC.
710135
In Commercial Distribution

  • 00733657230635 ()
  • 00733657299281 ()
2970008478

  • Movement-resistance gait rehabilitation device

BLT GT DISP BL 70 IN MET BUK CS 36 - 00733657230604

No Description
ALIMED, INC.
710132
In Commercial Distribution

  • 00733657230604 ()
  • 00733657299274 ()
2970008477

  • Movement-resistance gait rehabilitation device

GAIT BELT DISP BLUE 54 IN PLASTIC BUCKLECS 100 - 00733657230598

No Description
ALIMED, INC.
710131
In Commercial Distribution

  • 00733657230598 ()
  • 00733657299267 ()
2970008476

  • Movement-resistance gait rehabilitation device

GAIT BELT DISP BLUE 54 IN PLASTIC BUCKLE CS 36 - 00733657230574

No Description
ALIMED, INC.
710129
In Commercial Distribution

  • 00733657230574 ()
  • 00733657299250 ()
2970008475

  • Movement-resistance gait rehabilitation device

GAIT BELT DISP BLUE 54 IN METAL BUCKLE CS 100 - 00733657230567

No Description
ALIMED, INC.
710128
In Commercial Distribution

  • 00733657230567 ()
  • 00733657299243 ()
2970008474

  • Movement-resistance gait rehabilitation device

GAIT BELT DISP BLUE 54 IN METAL BUCKLE CS 36 - 00733657230543

No Description
ALIMED, INC.
710126
In Commercial Distribution

  • 00733657230543 ()
  • 00733657299236 ()
2970008473

  • Movement-resistance gait rehabilitation device

BELT QC AMBULATION - 00733657229271

No Description
ALIMED, INC.
77905
In Commercial Distribution

  • 00733657229271 ()
2970010245

  • Movement-resistance gait rehabilitation device

GAIT BELT RED/WHIT/BLUE 70 INCH METAL BUCKLE - 00733657228823

No Description
ALIMED, INC.
77178
In Commercial Distribution

  • 00733657228823 ()
2970010129

  • Movement-resistance gait rehabilitation device
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