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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 - 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

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

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

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 METAL BUCKLE CS 100 - 00733657230567

No Description
ALIMED, INC.
710128
In Commercial Distribution

  • 00733657230567 ()
  • 00733657299243 ()
2970008474

  • 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

GAIT BELT RED/WHIT/BLUE 54 INCH METAL BUCKLE - 00733657228793

No Description
ALIMED, INC.
77175
In Commercial Distribution

  • 00733657228793 ()
2970010127

  • Movement-resistance gait rehabilitation device
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