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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HOLDER EX1210102 GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX1210102
In Commercial Distribution

  • 00613994922175 ()


  • Bone graft packing block
POSITIONER EX1110248 GRAFT GUIDE
MEDTRONIC SOFAMOR DANEK, INC.
EX1110248
In Commercial Distribution

  • 00613994922168 ()


  • Bone graft packing block
IMPACTOR X0411311 GRAFT 45 DEG
MEDTRONIC SOFAMOR DANEK, INC.
X0411311
In Commercial Distribution

  • 00613994994998 ()


  • Bone graft packing block
PUSHER X0411304 GRAFT MEDIUM
MEDTRONIC SOFAMOR DANEK, INC.
X0411304
In Commercial Distribution

  • 00613994994974 ()


  • Bone graft packing block
LOADING BLOCK EX0311274 GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0311274
In Commercial Distribution

  • 00613994992543 ()


  • Bone graft packing block
IMPACTOR X0411310 GRAFT 15 DEG
MEDTRONIC SOFAMOR DANEK, INC.
X0411310
In Commercial Distribution

  • 00613994994981 ()


  • Bone graft packing block
PUSHER X0411303 GRAFT SMALL
MEDTRONIC SOFAMOR DANEK, INC.
X0411303
In Commercial Distribution

  • 00613994994967 ()


  • Bone graft packing block
STATION EX0717016 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0717016
In Commercial Distribution

  • 00763000056223 ()


  • Bone graft packing block
Graft Block
SEASPINE ORTHOPEDICS CORPORATION
RA2-006003
In Commercial Distribution

  • 10889981216535 ()
RA2-006003

  • Bone graft packing block
The MIE - Gamma Camera Systems for nuclear medicine is used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients.
MiE medical imaging electronics GmbH
PICOLA-SCINTRON
In Commercial Distribution

  • 04260484140074 ()


  • Stationary gamma camera system
The MIE - Gamma Camera Systems for nuclear medicine is used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients.
MiE medical imaging electronics GmbH
SYNGULA-SCINTRON
In Commercial Distribution

  • 04260484140043 ()


  • Stationary gamma camera system
Gait Trainer
RIFTON EQUIPMENT
K610
In Commercial Distribution

  • 00850001752237 ()


  • Gait rehabilitation frame, manual
BLOCK EX0815056 LOADING 5 6 7 8MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0815056
In Commercial Distribution

  • 00643169671942 ()


  • Bone graft packing block
PACKING STATION EX0315064 CR GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0315064
In Commercial Distribution

  • 00643169631007 ()


  • Bone graft packing block
LID 7426010 PACKING FIXTURE
MEDTRONIC SOFAMOR DANEK, INC.
7426010
In Commercial Distribution

  • 00643169572645 ()


  • Bone graft packing block
FIXTURE 7426009 IMPLANT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
7426009
In Commercial Distribution

  • 00643169572638 ()


  • Bone graft packing block
STATION EX0516086 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0516086
In Commercial Distribution

  • 00643169793934 ()


  • Bone graft packing block
Incision Locator
GLOBUS MEDICAL, INC.
675.404
In Commercial Distribution

  • 00849044042283 ()


  • Cardiovascular patch, animal-derived
Platform
Medyssey Co., Ltd.
NAPF-001
In Commercial Distribution

  • 08800042415952 ()


  • Bone graft packing block
TLIF Bone Packing Block
Medyssey Co., Ltd.
NTPB-001
In Commercial Distribution

  • 08800048410296 ()


  • Bone graft packing block
Platform - W11 (Dynamic/Varian&EP)
Medyssey Co., Ltd.
NDPF-001
In Commercial Distribution

  • 08800048402215 ()


  • Bone graft packing block
ACF GRAFT PACKING BLOCK
Synthes GmbH
396.996
In Commercial Distribution

  • H9813969960 ()
  • 10705034778204 ()
396996

  • Bone graft packing block
PACKING BLOCK FOR ZERO-P IMPLANTS
Synthes GmbH
03.617.984
In Commercial Distribution

  • 07611819969780 ()
  • H981036179840 ()
  • 10705034717388 ()
03617984

  • Bone graft packing block
MODIFIED INSTRUMENT BONE GRAFT SLIDE
DEPUY SPINE, LLC
698341734
In Commercial Distribution

  • 10705034480749 ()
698341734

  • Bone graft packing block
MODIFIED INSTRUMENT PACKING BLOCK
DEPUY SPINE, LLC
698344404
In Commercial Distribution

  • 10705034567648 ()
698344404

  • Bone graft packing block
GRAFT PACKING BLOCK
Synthes GmbH
03.841.055
In Commercial Distribution

  • 07611819473140 ()
  • H981038410550 ()
  • 10705034732350 ()
03841055

  • Bone graft packing block
MODIFIED INSTRUMENT FILLER BLOCK
DEPUY SPINE, LLC
698335436
In Commercial Distribution

  • 10705034371184 ()
698335436

  • Bone graft packing block
UNIVERSAL INSTRUMENTS FILLER BLOCK
DEPUY SPINE, LLC
273310200
In Commercial Distribution

  • 10705034188034 ()
273310200

  • Bone graft packing block
Packing Block(C7)
Medyssey Co., Ltd.
N7PB-001
In Commercial Distribution

  • 08800048404127 ()


  • Bone graft packing block
NxSTEP Unweighing System, 115VAC
BIODEX MEDICAL SYSTEMS, INC.
950-485
In Commercial Distribution

  • 00718175004852 ()
950-485

  • Mobile gait rehabilitation system, harness-support
NxSTEP Unweighing System, without Harness
BIODEX MEDICAL SYSTEMS, INC.
950-484
In Commercial Distribution

  • 00718175004845 ()
950-484

  • Mobile gait rehabilitation system, harness-support
NxSTEP Unweighing System
BIODEX MEDICAL SYSTEMS, INC.
945-480
In Commercial Distribution

  • 00718175004807 ()
945-480

  • Mobile gait rehabilitation system, harness-support
OCELOT STACKABLE CAGE SYSTEM FILLER BLOCK
DEPUY SPINE, LLC
273400900
In Commercial Distribution

  • 10705034189727 ()
273400900

  • Bone graft packing block
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
PsiF Post Packer (Long Impactor) Instrument
OMNIA MEDICAL, LLC
01-01-0010
In Commercial Distribution

  • 00843511100636 ()
01-01-0010

  • Bone graft packing block
The Optimal-G is a robotics-based powered exercise equipment intended to redevelop muscles and to restore motion to joints during the rehabilitation of a patient recovering from a stroke or other neuromuscular condition. The Optimal-G enables passive and allows active motions of the lower limbs, which are carried out by a single robotic guide. The robotic guide is modular, and designed to be appropriate for use both in the in-patient and outpatient facilities. It incorporates sensors for accurate motion control of the robotic guide and provides measures of patient performance.
MOTORIKA MEDICAL (ISRAEL) LTD
A
In Commercial Distribution

  • 07290017844312 ()
OG01-0000-01

  • Gait rehabilitation system harness
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1809
In Commercial Distribution

  • 09348215039783 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1609
In Commercial Distribution

  • 09348215039776 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1509
In Commercial Distribution

  • 09348215039769 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1409
In Commercial Distribution

  • 09348215039752 ()


  • Orthopaedic broach
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