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

  • 09348215074722 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
101-139
In Commercial Distribution

  • 09348215055356 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-160
In Commercial Distribution

  • 09348215055899 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-161
In Commercial Distribution

  • 09348215055905 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-162
In Commercial Distribution

  • 09348215055912 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-163
In Commercial Distribution

  • 09348215055929 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-164
In Commercial Distribution

  • 09348215055936 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-165
In Commercial Distribution

  • 09348215055943 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-166
In Commercial Distribution

  • 09348215055950 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-168
In Commercial Distribution

  • 09348215055967 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-170
In Commercial Distribution

  • 09348215055974 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-158
In Commercial Distribution

  • 09348215055875 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-159
In Commercial Distribution

  • 09348215055882 ()


  • Surgical implant template, reusable
Origin R Broach Size 18
ORTHOMEDFLEX LLC
112-44-1118
In Commercial Distribution

  • M7161124411180 ()


  • Orthopaedic broach
Origin R Broach Size 16
ORTHOMEDFLEX LLC
112-44-1116
In Commercial Distribution

  • M7161124411160 ()


  • Orthopaedic broach
Origin R Broach Size 13
ORTHOMEDFLEX LLC
112-44-1113
In Commercial Distribution

  • M7161124411130 ()


  • Orthopaedic broach
Origin R Broach Size 12
ORTHOMEDFLEX LLC
112-44-1112
In Commercial Distribution

  • M7161124411120 ()


  • Orthopaedic broach
Origin R Broach Size 11
ORTHOMEDFLEX LLC
112-44-1111
In Commercial Distribution

  • M7161124411110 ()


  • Orthopaedic broach
Origin R Broach Size 15
ORTHOMEDFLEX LLC
112-44-1115
In Commercial Distribution

  • M7161124411150 ()


  • Orthopaedic broach
Origin R Broach Size 14
ORTHOMEDFLEX LLC
112-44-1114
In Commercial Distribution

  • M7161124411140 ()


  • Orthopaedic broach
Origin R Broach Size 10
ORTHOMEDFLEX LLC
112-44-1110
In Commercial Distribution

  • M7161124411100 ()


  • Orthopaedic broach
Origin R Broach Size 9
ORTHOMEDFLEX LLC
112-44-1109
In Commercial Distribution

  • M7161124411090 ()


  • Orthopaedic broach
Origin R Broach Size 8
ORTHOMEDFLEX LLC
112-44-1108
In Commercial Distribution

  • M7161124411080 ()


  • Orthopaedic implant impactor, reusable
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
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 700 model allows for a patient weight capacity of up to 700 pounds with a dynamic body-weight support range of 25 to 300 pounds.
ARETECH, LLC
OV-700
In Commercial Distribution

  • 00850018836043 ()


  • Gait rehabilitation frame, electric
CURVED TAMP
SpineArt SA
SPE-US 01 42-N
In Commercial Distribution

  • 07640375236173 ()
SPE-US 01 42-N

  • Bone graft packing block
PLIF SG INSTRUMENTS CAGE FILLER BLOCK
DEPUY SPINE, LLC
273126001
Not in Commercial Distribution

  • 10705034186870 ()
273126001

  • Bone graft packing block
60" Gait Belt, Metal Buckle, Navy Blue
Asp Global, LLC
GB60MBNB
In Commercial Distribution

  • 00840216117952 ()


  • Gait rehabilitation system harness
60" Gait Belt, Metal Buckle, Natural
Asp Global, LLC
GB60MBN
In Commercial Distribution

  • 00840216117945 ()


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

  • 00840216114067 ()


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

  • 00840216114050 ()


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

  • 00840216114043 ()


  • Gait rehabilitation system harness
72" Gait Belt, Metal Buckle, Pastel
Asp Global, LLC
GB72MBP
In Commercial Distribution

  • 00840216114029 ()


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

  • 00840216114012 ()


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

  • 00840216114005 ()


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

  • 00840216113992 ()


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

  • 00840216113985 ()


  • Gait rehabilitation system harness
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
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
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
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