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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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SRH3427LBlue Sky Bio, LLC - 00810060223109

Bone Condenser 6/7
BLUE SKY BIO LLC
STPCND67
In Commercial Distribution

  • 00810060223109 ()


  • Bone graft packing block

SRH3427LBlue Sky Bio, LLC - 00810060223093

Bone Condenser 4/5
BLUE SKY BIO LLC
STPCND45
In Commercial Distribution

  • 00810060223093 ()


  • Bone graft packing block

SRH3427LBlue Sky Bio, LLC - 00810060223086

Bone Condenser 2/3
BLUE SKY BIO LLC
STPCND23
In Commercial Distribution

  • 00810060223086 ()


  • Bone graft packing block

SRH3427LBlue Sky Bio, LLC - 00810060223079

Bone Condenser 10/11
BLUE SKY BIO LLC
STPCND1011
In Commercial Distribution

  • 00810060223079 ()


  • Bone graft packing block

Surgical Instrument - 08800089476398

No Description
Jeil Medical Corporation
111-480
In Commercial Distribution

  • 08800089476398 ()


  • Bone graft packing block

ENDOSKELETON® TCS - 00191375028345

Graft Packing & Screw Reference Block
TITAN SPINE, LLC
5210-1017
Not in Commercial Distribution

  • 00191375028345 ()

  • Height: 1 Inch
  • Width: 2 Inch
  • Length: 1.5 Inch
5210-1017

  • Bone graft packing block

ReWalk(TM) Rehabilitaiton - 00861803000327

Powered Exoskeleton - rehabilitation institution use
LIFEWARD LTD
50-30-0001
In Commercial Distribution

  • 00861803000327 ()


  • Programmable ambulation exoskeleton, clinical

ReStore - 00860001744507

The device is a lightweight, wearable, battery-powered soft orthotic exosuit intended to be used to preform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia / hemiparesis due to stroke.
LIFEWARD LTD
50-40-0001
In Commercial Distribution

  • 00860001744507 ()


  • Programmable ambulation exoskeleton, clinical

Indego Therapy - M704501110001

Indego Therapy is a computerized, adjustable-fit powered exoskeleton, designed to restore walking function for impaired individuals.
Ekso Bionics, Inc.
501-110-001
Not in Commercial Distribution

  • M704501110001 ()


  • Programmable ambulation exoskeleton, clinical

Indego - M704501100000

Indego is a computerized, powered exoskeleton, designed to restore walking function for impaired individuals.
Ekso Bionics, Inc.
501-100-000
Not in Commercial Distribution

  • M704501100000 ()


  • Programmable ambulation exoskeleton, clinical
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