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

  • 08809301160206 ()


  • Glucose monitoring system IVD, home-use
No Description
PHILOSYS Co., Ltd
PG-310
In Commercial Distribution

  • 08809301160145 ()


  • Glucose monitoring system IVD, home-use
No Description
PHILOSYS Co., Ltd
PG-310
In Commercial Distribution

  • 08809301160077 ()


  • Glucose monitoring system IVD, home-use
No Description
U&I CORPORATION
SG0019
In Commercial Distribution

  • 08800015946414 ()


  • Bone graft packing block
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
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 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 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
Robotic-assisted gait trainer
Reha Technology AG
G-EO System
In Commercial Distribution

  • 07640174420018 ()


  • Treadmill/elliptical gait rehabilitation system
Robotic-assisted gait trainer
Reha Technology AG
G-EO
In Commercial Distribution

  • 07640174420032 ()


  • Treadmill/elliptical gait rehabilitation system
MDCK W48/18
DIAGNOSTIC HYBRIDS, INC.
83-4818
In Commercial Distribution

  • 30014613334057 ()
83-4818

  • Cell culture line IVD
MDCK CELLS MWP W48/12F
DIAGNOSTIC HYBRIDS, INC.
83-4812
In Commercial Distribution

  • 30014613334040 ()
83-4812

  • Cell culture line IVD
MDCK MWP W384/384F
DIAGNOSTIC HYBRIDS, INC.
83-384384
In Commercial Distribution

  • 30014613334033 ()
83-384384

  • Cell culture line IVD
MDCK W24/24
DIAGNOSTIC HYBRIDS, INC.
83-2424
In Commercial Distribution

  • 30014613334026 ()
83-2424

  • Cell culture line IVD
MDCK W24/18
DIAGNOSTIC HYBRIDS, INC.
83-2418
In Commercial Distribution

  • 30014613334019 ()
83-2418

  • Cell culture line IVD
MDCK W24/12
DIAGNOSTIC HYBRIDS, INC.
83-2412
In Commercial Distribution

  • 30014613334002 ()
83-2412

  • Cell culture line IVD
MDCK PLATES
DIAGNOSTIC HYBRIDS, INC.
83-0606
In Commercial Distribution

  • 30014613333999 ()
83-0606

  • Cell culture line IVD
MDCK CELLS TUBE CULT
DIAGNOSTIC HYBRIDS, INC.
83-0600
In Commercial Distribution

  • 30014613333982 ()
83-0600

  • Cell culture line IVD
MDCK SV/CS
DIAGNOSTIC HYBRIDS, INC.
83-0102
In Commercial Distribution

  • 30014613333975 ()
83-0102

  • Cell culture line IVD
MDCK FRZER VIAL
DIAGNOSTIC HYBRIDS, INC.
83-00050
In Commercial Distribution

  • 30014613333968 ()
83-00050

  • Cell culture line IVD
L-929 FLK 150 SQ CM
DIAGNOSTIC HYBRIDS, INC.
78-T150
In Commercial Distribution

  • 30014613333890 ()
78-T150

  • Cell culture line IVD
L-929 FLK 75 SQ CM
DIAGNOSTIC HYBRIDS, INC.
78-T075
In Commercial Distribution

  • 30014613333883 ()
78-T075

  • Cell culture line IVD
L-929 25ML FLASK- NO ANTIBIOTI
DIAGNOSTIC HYBRIDS, INC.
78-T025AF
In Commercial Distribution

  • 30014613333876 ()
78-T025AF

  • Cell culture line IVD
RD FLK 75 SQ CM
DIAGNOSTIC HYBRIDS, INC.
76-T075
In Commercial Distribution

  • 30014613333869 ()
76-T075

  • Cell culture line IVD
RD FLASK 25 SQ CM
DIAGNOSTIC HYBRIDS, INC.
76-T025
In Commercial Distribution

  • 30014613333852 ()
76-T025

  • Cell culture line IVD
RD CELLS TUBE CULT REG DENS
DIAGNOSTIC HYBRIDS, INC.
76-0600R
In Commercial Distribution

  • 30014613333845 ()
76-0600R

  • Cell culture line IVD
RD CELLS TUBE CULT LIGHT DENS
DIAGNOSTIC HYBRIDS, INC.
76-0600L
In Commercial Distribution

  • 30014613333838 ()
76-0600L

  • Cell culture line IVD
RD FROZEN SUSP. 50 MER
DIAGNOSTIC HYBRIDS, INC.
76-00050
In Commercial Distribution

  • 30014613333821 ()
76-00050

  • Cell culture line IVD
HELA-229 FLASK 225 SQ CM
DIAGNOSTIC HYBRIDS, INC.
75-T225
In Commercial Distribution

  • 30014613333814 ()
75-T225

  • Cell culture line IVD
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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