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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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HAL for Medical Use - 04560340090964

Number of legs: Double Leg length: Long Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DLMUS
In Commercial Distribution

  • 04560340090964 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340090957

Number of legs: Double Leg length: Medium Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DMMUS
In Commercial Distribution

  • 04560340090957 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340090940

Number of legs: Double Leg length: Short Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DSMUS
In Commercial Distribution

  • 04560340090940 ()


  • Neuro-controlled ambulation exoskeleton

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
Innosys Co., Ltd.
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

Gait Belt - 00616784435411

Gait Belt- Plastic Buckle, Multi-Color, 60"x2"
DYNAREX CORPORATION
4354
In Commercial Distribution

  • 00616784435435 ()
  • 00616784435411 ()


  • Gait rehabilitation system harness

Gait Belt - 00616784435312

Gait Belt, Metal Buckle, Multi-color, 60"x2"
DYNAREX CORPORATION
4353
In Commercial Distribution

  • 00616784435336 ()
  • 00616784435312 ()


  • Gait rehabilitation system harness

Gait Belt - 00616784435213

Gait Belt- Metal Buckle, Natural Color, 60"x2"
DYNAREX CORPORATION
4352
In Commercial Distribution

  • 00616784435237 ()
  • 00616784435213 ()


  • Gait rehabilitation system harness

Gait Belt - 00616784434513

Gait Belt, Wipeable, Vinyl, Plastic Buckle, Red and Black
DYNAREX CORPORATION
4345
In Commercial Distribution

  • 00616784434537 ()
  • 00616784434513 ()


  • Gait rehabilitation system harness

Gait Belt - 00616784434414

Gait Belt, Antimicrobial, Metal Buckle, Blue and White
DYNAREX CORPORATION
4344
In Commercial Distribution

  • 00616784434438 ()
  • 00616784434414 ()


  • Gait rehabilitation system harness

GAIT/TRANSFER BELT METAL BUCKLE PINSTRIPE 70IN - 00733657223897

No Description
ALIMED, INC.
7083
In Commercial Distribution

  • 00733657223897 ()
2970008349

  • Movement-resistance gait rehabilitation device

GAIT BELT WITH ODOR CONTROL 70IN - 00733657227666

No Description
ALIMED, INC.
70256
In Commercial Distribution

  • 00733657227666 ()
2970008129

  • Movement-resistance gait rehabilitation device

GAIT BELT WITH ODOR CONTROL 54IN - 00733657227673

No Description
ALIMED, INC.
70257
In Commercial Distribution

  • 00733657227673 ()
2970008130

  • 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

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 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 36 - 00733657230543

No Description
ALIMED, INC.
710126
In Commercial Distribution

  • 00733657230543 ()
  • 00733657299236 ()
2970008473

  • 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

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 - 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
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