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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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OMEGO - 09120077180083

The OMEGO is a robotic pre-gait therapy system for the rehabilitation of patients with neurologic disorders.
tyromotion GmbH
1
In Commercial Distribution

  • 09120077180083 ()


  • Treadmill/elliptical gait rehabilitation system

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

Origin Size 18 Template - 09348215074807

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-118
In Commercial Distribution

  • 09348215074807 ()


  • Surgical implant template, reusable

Origin Size 16 Template - 09348215074791

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-116
In Commercial Distribution

  • 09348215074791 ()


  • Surgical implant template, reusable

Origin Size 15 Template - 09348215074784

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-115
In Commercial Distribution

  • 09348215074784 ()


  • Surgical implant template, reusable

Origin Size 14 Template - 09348215074777

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-114
In Commercial Distribution

  • 09348215074777 ()


  • Surgical implant template, reusable

Origin Size 13 Template - 09348215074760

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-113
In Commercial Distribution

  • 09348215074760 ()


  • Surgical implant template, reusable

Origin Size 12 Template - 09348215074753

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-112
In Commercial Distribution

  • 09348215074753 ()


  • Surgical implant template, reusable

Origin Size 11 Template - 09348215074746

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-111
In Commercial Distribution

  • 09348215074746 ()


  • Surgical implant template, reusable

Origin Size 10 Template - 09348215074739

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-110
In Commercial Distribution

  • 09348215074739 ()


  • Surgical implant template, reusable

Origin Size 9 Template - 09348215074722

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-109
In Commercial Distribution

  • 09348215074722 ()


  • Surgical implant template, reusable

Origin Size 8 Template - 09348215074715

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-108
In Commercial Distribution

  • 09348215074715 ()


  • Surgical implant template, reusable

Small Pacer - 00850001752244

Gait Trainer
RIFTON EQUIPMENT
K620
In Commercial Distribution

  • 00850001752244 ()


  • Gait rehabilitation frame, manual

Mini Pacer - 00850001752237

Gait Trainer
RIFTON EQUIPMENT
K610
In Commercial Distribution

  • 00850001752237 ()


  • Gait rehabilitation frame, manual

E-Pacer - 00858101008292

Powered gait trainer and transfer device
RIFTON EQUIPMENT
K660
In Commercial Distribution

  • 00858101008292 ()


  • Gait rehabilitation electronic walker

Large Pacer - 00858101008278

Gait Trainer
RIFTON EQUIPMENT
K640
In Commercial Distribution

  • 00858101008278 ()


  • Gait rehabilitation frame, manual

XL Pacer - 00858101008285

Gait Trainer
RIFTON EQUIPMENT
K650
In Commercial Distribution

  • 00858101008285 ()


  • Gait rehabilitation frame, manual

Medium Pacer - 00858101008261

Gait Trainer
RIFTON EQUIPMENT
K630
In Commercial Distribution

  • 00858101008261 ()


  • Gait rehabilitation frame, manual

Health o meter professional - 00851628008066

Eye Level Digital Scale, Origin USA
Pelstar, LLC
501KL
In Commercial Distribution

  • 00851628008066 ()


  • Stand-on floor scale, electronic

MediChoice - 50885632110847

Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle Natural 2 X 72 Inch Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT722
In Commercial Distribution

  • 10885632110849 ()
  • 50885632110847 ()


  • Gait rehabilitation system harness

MediChoice - 50885632110830

Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle Pastel Stripe 2 X 72 Inch Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT721
In Commercial Distribution

  • 10885632110832 ()
  • 50885632110830 ()


  • Gait rehabilitation system harness

MediChoice - 50885632110823

Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle Natural 2 X 60 Inch Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT602
In Commercial Distribution

  • 10885632110825 ()
  • 50885632110823 ()


  • Gait rehabilitation system harness

MediChoice - 50885632110816

Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle Pastel Stripe 2 X 60 Inch Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT601
In Commercial Distribution

  • 10885632110818 ()
  • 50885632110816 ()


  • Gait rehabilitation system harness

MediChoice - 50885632110809

Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle Natural 2 X 54 Inch Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT542
In Commercial Distribution

  • 10885632110801 ()
  • 50885632110809 ()


  • Gait rehabilitation system harness

MediChoice - 50885632110793

Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle Pastel Stripe 2 X 54 Inch Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT541
In Commercial Distribution

  • 10885632110795 ()
  • 50885632110793 ()


  • Gait rehabilitation system harness

MediChoice - 20885632061643

Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle 2x72inch Yellow Latex Free Reusable MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT723
In Commercial Distribution

  • 10885632061646 ()
  • 20885632061643 ()


  • Gait rehabilitation system harness

MediChoice - 20885632061629

Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle 2x54 Inch Yellow Latex Free Reusable MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT543
In Commercial Distribution

  • 10885632061622 ()
  • 20885632061629 ()


  • Gait rehabilitation system harness

FREND - 08809317540825

FREND™ Blocking Reagent is provided in 15 tubes, the blocking reagent is buffer based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The Blocking Reagent is provided in a dried solid state.
NanoEnTek, Inc.
FREND Blocking Reagent
In Commercial Distribution

  • 08809317540825 ()
FRBR 015

  • Immunohistochemistry endogenous protein blocking reagent IVD

FREND - 08809317540566

FREND™ TSH Linearity Kit is intended for use as an assayed linearity material for the thyroid stimulating hormone (TSH) on the FREND™ System. The Linearity Kit is for the FREND™ System only. FREND™ TSH Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution.
NanoEnTek, Inc.
FREND Vitamin D Linearity Kit
In Commercial Distribution

  • 08809317540566 ()
FLK-VTD

  • Non-blood cell primer/calibrator/control material IVD, reagent
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