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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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Ovation 400 - 00850018836029

The Ovation system is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. Ovation should never be used to lift subjects off the ground and should never be connected to inanimate objects. Ovation should only be operated by clinicians and trained healthcare professionals who have read and understand the instructions for use and have passed the Ovation training competency exam conducted by an Aretech trainer or a certified staff trainer. The Ovation 400 model allows for a patient weight capacity of up to 400 pounds with a dynamic body-weight support range of 10 to 200 pounds.
ARETECH, LLC
OV-400
In Commercial Distribution

  • 00850018836029 ()


  • Gait rehabilitation frame, electric

ZeroG Gait & Balance System - 00850018836012

The ZeroG Gait & Balance System is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. ZeroG can also be used to train subjects ambulating on a treadmill. ZeroG should never be used to lift and transport subjects, and should never be connected to inanimate objects. ZeroG should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the ZeroG training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
ZGGB-V3
In Commercial Distribution

  • 00850018836012 ()


  • Gait rehabilitation frame, electric

Luminaire BWS Treadmill System - 00850018836272

Luminaire is a robotic body-weight support system fixed above a slat-belt treadmill. The system provides precise levels of dynamic body-weight support to the patient as they walk on the treadmill, while simultaneously preventing falls. Clinician seating and footplates can be used for situations where manual-assisted ambulation is desired. The Luminaire System is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice ambulating on a treadmill. Luminaire should never be used to lift subjects and should never be connected to inanimate objects. Luminaire should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the Luminaire training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
LU-001
In Commercial Distribution

  • 00850018836272 ()


  • Gait rehabilitation frame, electric

ZeroG 3D 3-Dimensional BWS System - 00850018836265

ZeroG 3D is a robotic body-weight support system which automatically tracks patients as they move freely in any direction. The dynamic body-weight support offloads a percentage of the patient’s weight as they perform activities in a full 3-dimensional workspace, while the advanced fall protection provides the highest level of safety. The ZeroG 3D System is intended to assist subjects who have experienced neurological and orthopedic injures as they practice therapeutic activities related to walking and balance activities. ZeroG 3D can also be used to train subjects ambulating on a treadmill. ZeroG 3D should never be used to lift and transport subjects and should never be connected to inanimate objects. ZeroG 3D should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the ZeroG 3D training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
ZG3D-001
In Commercial Distribution

  • 00850018836265 ()


  • Gait rehabilitation frame, electric

BabyG Early Mobilization System - 00850018836258

The BabyG Early Mobilization System is a robotic body-weight support system which automatically tracks patients as they move freely in any direction. The dynamic body-weight support offloads a percentage of the patient’s weight as they perform activities in a full 3-dimensional workspace, while the advanced fall protection provides the highest level of safety. The BabyG System is intended to assist subjects weighing 50 pounds or less as they practice therapeutic activities related to walking and balance activities. BabyG should never be used to lift and transport subjects and should never be connected to inanimate objects. BabyG should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the BabyG training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
BG-001
In Commercial Distribution

  • 00850018836258 ()


  • Gait rehabilitation frame, electric

ZESPIN SI Joint Fusion System - 00840273312239

BONE GRAFT PACKING BLOCK
Aegis Spine, Inc.
SI01-0501
In Commercial Distribution

  • 00840273312239 ()
SI01-0501

  • Bone graft packing block

PRIMO - 00840216117952

60" Gait Belt, Metal Buckle, Navy Blue
Asp Global, LLC
GB60MBNB
In Commercial Distribution

  • 00840216117952 ()


  • Gait rehabilitation system harness

PRIMO - 00840216117945

60" Gait Belt, Metal Buckle, Natural
Asp Global, LLC
GB60MBN
In Commercial Distribution

  • 00840216117945 ()


  • Gait rehabilitation system harness

PRIMO - 00840216114067

72" Gait Belt, Quick Release Buckle, Pastel
Asp Global, LLC
GB72QRP
In Commercial Distribution

  • 00840216114067 ()


  • Gait rehabilitation system harness

PRIMO - 00840216114050

72" Gait Belt, Quick Release Buckle, Natural w/ Red & Blue Stripe
Asp Global, LLC
GB72QRNRB
In Commercial Distribution

  • 00840216114050 ()


  • Gait rehabilitation system harness

PRIMO - 00840216114043

72" Gait Belt, Quick Release Buckle, Navy Blue
Asp Global, LLC
GB72QRNB
In Commercial Distribution

  • 00840216114043 ()


  • Gait rehabilitation system harness

PRIMO - 00840216114029

72" Gait Belt, Metal Buckle, Pastel
Asp Global, LLC
GB72MBP
In Commercial Distribution

  • 00840216114029 ()


  • Gait rehabilitation system harness

PRIMO - 00840216114012

72" Gait Belt, Metal Buckle, Navy Blue
Asp Global, LLC
GB72MBNB
In Commercial Distribution

  • 00840216114012 ()


  • Gait rehabilitation system harness

PRIMO - 00840216114005

60" Gait Belt, Quick Release Buckle, Pastel
Asp Global, LLC
GB60QRP
In Commercial Distribution

  • 00840216114005 ()


  • Gait rehabilitation system harness

PRIMO - 00840216113992

60" Gait Belt, Quick Release Buckle, Navy Blue
Asp Global, LLC
GB60QRNB
In Commercial Distribution

  • 00840216113992 ()


  • Gait rehabilitation system harness

PRIMO - 00840216113985

60" Gait Belt, Quick Release Buckle, Natural
Asp Global, LLC
GB60QRN
In Commercial Distribution

  • 00840216113985 ()


  • Gait rehabilitation system harness

PRIMO - 00840216113978

60" Gait Belt, Quick Release Buckle, Natural w/ Red & Blue Stripe
Asp Global, LLC
GB60QRNRB
In Commercial Distribution

  • 00840216113978 ()


  • Gait rehabilitation system harness

PRIMO - 00840216107052

BELT, QUICK CLEAN GAIT, PINK, 36", METAL BUCKLE WITH CLAMP, EASY TO CLEAN LAMINATED 2" WEBBING, LATEX-FREE, 1EA/BG, 40BG/CS
Asp Global, LLC
GBARQM36PK
In Commercial Distribution

  • 00840216107052 ()


  • Gait rehabilitation system harness

PRIMO - 00840216107045

BELT, QUICK CLEAN GAIT, BLUE, 60", METAL BUCKLE WITH CLAMP, EASY TO CLEAN LAMINATED 2" WEBBING, LATEX-FREE, 1EA/BG, 40BG/CS
Asp Global, LLC
GBARQM60BL
In Commercial Distribution

  • 00840216107045 ()


  • Gait rehabilitation system harness

PRIMO - 00840216107038

BELT, QUICK CLEAN GAIT, BLACK, 72", METAL BUCKLE WITH CLAMP, EASY TO CLEAN LAMINATED 2" WEBBING, LATEX-FREE, 1EA/BG, 40BG/CS
Asp Global, LLC
GBARQM72BK
In Commercial Distribution

  • 00840216107038 ()


  • Gait rehabilitation system harness

PRIMO - 00840216105737

BELT GAIT NATURAL STRIPES WITH BLUE & RED 54"
Asp Global, LLC
GBANS54
In Commercial Distribution

  • 00840216105737 ()


  • Gait rehabilitation system harness

PRIMO/ASP MEDICAL - 00840216100138

72" GAIT BELT - NATURAL, 1/EA
Asp Global, LLC
GB72MBN
In Commercial Distribution

  • 00840216100138 ()


  • Gait rehabilitation system harness

Avery Breathing Pacemaker System - 00850252006066

Digital Transmitter for the Avery Breathing Pacemaker System
Avery Biomedical Devices Inc
NeurostimulatorTransmitter Digital
In Commercial Distribution

  • 00850252006066 ()
Spirit

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system

Avery Breathing Pacemaker System - 00850252006059

No Description
Avery Biomedical Devices Inc
Transtelephonic Monitor
Not in Commercial Distribution

  • 00850252006059 ()
TTM

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system

Avery Breathing Pacemaker System - 00850252006042

(902A) 2.0 m Lead Length
Avery Biomedical Devices Inc
External Antenna
In Commercial Distribution

  • 00850252006042 ()
902AL

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system

Avery Breathing Pacemaker System - 00850252006035

(902A) 1.0 m Lead Length
Avery Biomedical Devices Inc
External Antenna
In Commercial Distribution

  • 00850252006035 ()
902A

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system

Avery Breathing Pacemaker System - 00850252006028

No Description
Avery Biomedical Devices Inc
Neurostimulator Electrode Implant
In Commercial Distribution

  • 00850252006028 ()
E377-05

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system

Avery Breathing Pacemaker System - 00850252006011

No Description
Avery Biomedical Devices Inc
Neurostimulator Receiver Implant
In Commercial Distribution

  • 00850252006011 ()
I-110A

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system

Avery Breathing Pacemaker System - 00850252006004

No Description
Avery Biomedical Devices Inc
Neurostimulator Transmitter
In Commercial Distribution

  • 00850252006004 ()
MARK IV

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system

Origin - D960LVX00301

Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 30mm
In Commercial Distribution

  • D960LVX00301 ()
30101109

  • Dental appliance fabrication material, ceramic

Origin - D960LVX00281

Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 28mm
In Commercial Distribution

  • D960LVX00281 ()
30101108

  • Dental appliance fabrication material, ceramic

Origin - D960LVX00251

Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 25mm
In Commercial Distribution

  • D960LVX00251 ()
30101107

  • Dental appliance fabrication material, ceramic

Origin - D960LVX00241

Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 24mm
In Commercial Distribution

  • D960LVX00241 ()
30101110

  • Dental appliance fabrication material, ceramic

Origin - D960LVX00221

Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 22mm
In Commercial Distribution

  • D960LVX00221 ()
30101106

  • Dental appliance fabrication material, ceramic

Origin - D960LVX00201

Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 20mm
In Commercial Distribution

  • D960LVX00201 ()
30101105

  • Dental appliance fabrication material, ceramic

Origin - D960LVX00181

Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 18mm
In Commercial Distribution

  • D960LVX00181 ()
30101104

  • Dental appliance fabrication material, ceramic

Origin - D960LVX00161

Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 16mm
In Commercial Distribution

  • D960LVX00161 ()
30101103

  • Dental appliance fabrication material, ceramic

Origin - D960LVX00141

Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 14mm
In Commercial Distribution

  • D960LVX00141 ()
30101102

  • Dental appliance fabrication material, ceramic

Origin - D960LVX00121

Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 12mm
In Commercial Distribution

  • D960LVX00121 ()
30101101

  • Dental appliance fabrication material, ceramic

Origin - D960LVX00101

Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
Live 10mm
In Commercial Distribution

  • D960LVX00101 ()
30101100

  • Dental appliance fabrication material, ceramic
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