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Company Name Brand Name GMDN Term 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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Gmate® Origin Blood Glucose Monitoring System - 08809301160206

No Description
PHILOSYS Co., Ltd
PG-310
In Commercial Distribution

  • 08809301160206 ()


  • Glucose monitoring system IVD, home-use

Gmate® Origin Blood Glucose Monitoring System - 08809301160145

No Description
PHILOSYS Co., Ltd
PG-310
In Commercial Distribution

  • 08809301160145 ()


  • Glucose monitoring system IVD, home-use

Gmate® Origin Blood Glucose Monitoring System - 08809301160077

No Description
PHILOSYS Co., Ltd
PG-310
In Commercial Distribution

  • 08809301160077 ()


  • Glucose monitoring system IVD, home-use

Global Spinal Fixation System™ - 08800015946414

No Description
U&I CORPORATION
SG0019
In Commercial Distribution

  • 08800015946414 ()


  • Bone graft packing block

Geiger Smoke Evacuator - 00609960000527

Smoke Evacuator Unit and one FIL2 filter pack, 220 Volt. Primary Power Control: On/Off Switch — Illuminated when On Secondary Power Control: Maintained Foot Switch (optional) Noise Level: 60-65 db at 1 meter Overall Dimensions: 11″ W × 12″ H × 10″ D Weight: 18 pounds Cord: Detachable Hospital Grade Cord Enclosure: Grounded sheet steel, painted
DERMATOLOGIC LAB AND SUPPLY, INC.
SA-1A2
In Commercial Distribution

  • 00609960000527 ()
SA-1A2

  • Surgical plume evacuation system

Geiger Smoke Evacuator - 00609960000510

Smoke Evacuator Unit and one FIL2 filter pack, 110 Volt. Primary Power Control: On/Off Switch — Illuminated when On Secondary Power Control: Maintained Foot Switch (optional) Noise Level: 60-65 db at 1 meter Overall Dimensions: 11″ W × 12″ H × 10″ D Weight: 18 pounds Cord: Detachable Hospital Grade Cord Enclosure: Grounded sheet steel, painted
DERMATOLOGIC LAB AND SUPPLY, INC.
SA-1A
In Commercial Distribution

  • 00609960000510 ()
SA-1A

  • Surgical plume evacuation system

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

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

G-EO System - 07640174420018

Robotic-assisted gait trainer
Reha Technology AG
G-EO System
In Commercial Distribution

  • 07640174420018 ()


  • Treadmill/elliptical gait rehabilitation system

G-EO - 07640174420032

Robotic-assisted gait trainer
Reha Technology AG
G-EO
In Commercial Distribution

  • 07640174420032 ()


  • Treadmill/elliptical gait rehabilitation system

Fresh Cells - 30014613334057

MDCK W48/18
DIAGNOSTIC HYBRIDS, INC.
83-4818
In Commercial Distribution

  • 30014613334057 ()
83-4818

  • Cell culture line IVD

Fresh Cells - 30014613334040

MDCK CELLS MWP W48/12F
DIAGNOSTIC HYBRIDS, INC.
83-4812
In Commercial Distribution

  • 30014613334040 ()
83-4812

  • Cell culture line IVD

Fresh Cells - 30014613334033

MDCK MWP W384/384F
DIAGNOSTIC HYBRIDS, INC.
83-384384
In Commercial Distribution

  • 30014613334033 ()
83-384384

  • Cell culture line IVD

Fresh Cells - 30014613334026

MDCK W24/24
DIAGNOSTIC HYBRIDS, INC.
83-2424
In Commercial Distribution

  • 30014613334026 ()
83-2424

  • Cell culture line IVD

Fresh Cells - 30014613334019

MDCK W24/18
DIAGNOSTIC HYBRIDS, INC.
83-2418
In Commercial Distribution

  • 30014613334019 ()
83-2418

  • Cell culture line IVD

Fresh Cells - 30014613334002

MDCK W24/12
DIAGNOSTIC HYBRIDS, INC.
83-2412
In Commercial Distribution

  • 30014613334002 ()
83-2412

  • Cell culture line IVD

Fresh Cells - 30014613333999

MDCK PLATES
DIAGNOSTIC HYBRIDS, INC.
83-0606
In Commercial Distribution

  • 30014613333999 ()
83-0606

  • Cell culture line IVD

Fresh Cells - 30014613333982

MDCK CELLS TUBE CULT
DIAGNOSTIC HYBRIDS, INC.
83-0600
In Commercial Distribution

  • 30014613333982 ()
83-0600

  • Cell culture line IVD

Fresh Cells - 30014613333975

MDCK SV/CS
DIAGNOSTIC HYBRIDS, INC.
83-0102
In Commercial Distribution

  • 30014613333975 ()
83-0102

  • Cell culture line IVD

Fresh Cells - 30014613333968

MDCK FRZER VIAL
DIAGNOSTIC HYBRIDS, INC.
83-00050
In Commercial Distribution

  • 30014613333968 ()
83-00050

  • Cell culture line IVD

Fresh Cells - 30014613333890

L-929 FLK 150 SQ CM
DIAGNOSTIC HYBRIDS, INC.
78-T150
In Commercial Distribution

  • 30014613333890 ()
78-T150

  • Cell culture line IVD

Fresh Cells - 30014613333883

L-929 FLK 75 SQ CM
DIAGNOSTIC HYBRIDS, INC.
78-T075
In Commercial Distribution

  • 30014613333883 ()
78-T075

  • Cell culture line IVD

Fresh Cells - 30014613333876

L-929 25ML FLASK- NO ANTIBIOTI
DIAGNOSTIC HYBRIDS, INC.
78-T025AF
In Commercial Distribution

  • 30014613333876 ()
78-T025AF

  • Cell culture line IVD

Fresh Cells - 30014613333869

RD FLK 75 SQ CM
DIAGNOSTIC HYBRIDS, INC.
76-T075
In Commercial Distribution

  • 30014613333869 ()
76-T075

  • Cell culture line IVD

Fresh Cells - 30014613333852

RD FLASK 25 SQ CM
DIAGNOSTIC HYBRIDS, INC.
76-T025
In Commercial Distribution

  • 30014613333852 ()
76-T025

  • Cell culture line IVD

Fresh Cells - 30014613333845

RD CELLS TUBE CULT REG DENS
DIAGNOSTIC HYBRIDS, INC.
76-0600R
In Commercial Distribution

  • 30014613333845 ()
76-0600R

  • Cell culture line IVD

Fresh Cells - 30014613333838

RD CELLS TUBE CULT LIGHT DENS
DIAGNOSTIC HYBRIDS, INC.
76-0600L
In Commercial Distribution

  • 30014613333838 ()
76-0600L

  • Cell culture line IVD

Fresh Cells - 30014613333821

RD FROZEN SUSP. 50 MER
DIAGNOSTIC HYBRIDS, INC.
76-00050
In Commercial Distribution

  • 30014613333821 ()
76-00050

  • Cell culture line IVD

Fresh Cells - 30014613333814

HELA-229 FLASK 225 SQ CM
DIAGNOSTIC HYBRIDS, INC.
75-T225
In Commercial Distribution

  • 30014613333814 ()
75-T225

  • Cell culture line IVD

Fresh Cells - 30014613333807

HELA-229 FLK 150 SQ CM
DIAGNOSTIC HYBRIDS, INC.
75-T150
In Commercial Distribution

  • 30014613333807 ()
75-T150

  • Cell culture line IVD
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