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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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Stat Profile - 00385480524278

Prime Calibrator Cartridge CCS Comp 300 Sample
NOVA BIOMEDICAL CORPORATION
PRIME
In Commercial Distribution

  • 00385480524278 ()
52427

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
  • Assisted reproduction centrifuge tube

STAT PROFILE - 00385480491877

Stat Profile pHOx Ultra/CCX Control CO-Ox Tri Level L7, 8 ,9 (amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480491877 ()
  • 00385489491878 ()
49187

  • Assisted reproduction centrifuge tube

STAT PROFILE - 00385480491846

Stat Profile pHOx Ultra/CCX Control Chemistry L4, 5 (amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480491846 ()
  • 00385489491847 ()
49184

  • Assisted reproduction centrifuge tube

STAT PROFILE - 00385480489355

Stat Profile pHOx Ultra/CCX Blood Gas Controls Multipack L1, 2, 3 (Amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480489355 ()
  • 00385489489356 ()
48935

  • Assisted reproduction centrifuge tube

NEBULAE SRS Laparoscopic Surgical Pump - 00817183020684

No Description
NORTHGATE TECHNOLOGIES INC.
7-700-00
In Commercial Distribution

  • 00817183020684 ()


  • Surgical plume evacuation system

Tranquil-C™ - B6788222280

Cervical Graft Block
NEXUS SPINE, L.L.C.
822228
In Commercial Distribution

  • B6788222280 ()


  • Bone graft packing block

Tranquil-L™ - B6788221300

Steerable Graft Block
NEXUS SPINE, L.L.C.
822130
In Commercial Distribution

  • B6788221300 ()


  • Bone graft packing block

Tranquil-L™ - B6788220050

Lumbar Graft Block
NEXUS SPINE, L.L.C.
822005
In Commercial Distribution

  • B6788220050 ()


  • Bone graft packing block

Tranquil-L™ - B6788228000

ALIF Graft Block
NEXUS SPINE, L.L.C.
822800
In Commercial Distribution

  • B6788228000 ()


  • Bone graft packing block

LiteGait - 00850040235012

LiteGait is a Physical Therapy Patient lifting device that allows for body weight support gait therapy.
Mobility Research, Inc.
ALL LiteGait devices
In Commercial Distribution

  • 00850040235012 ()
N/A

  • Gait rehabilitation system harness

MiE - Gamma Camera Systems - 04260484140074

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

MiE - Gamma Camera Systems - 04260484140043

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

ECAM-SCINTRON - 04260484140036

The ECAM SCINTRON Gamma Camera System is a remanufactured Siemens Gamma Camera with MiE Workstation. It is designed for diagnostic nuclear medicine used to perform static, dynamic and gated studies (non positron emitting tomography), as well as SPECT or planar procedure on standing, seated or recumbent patients. The ECAM SCINTRON Gamma Camera System is substantially equivalent to the legally market device e.cam, K963983, from Siemens and our device SCINTRON, K101 01 3. The changes incorporated into the remanufactured ECAM Gamma Camera include economical and ecological issues. This closes the gap between more durable electronics and mechanics lifetimes and shortened development cycles.
MiE medical imaging electronics GmbH
ECAM-SCINTRON
In Commercial Distribution

  • 04260484140036 ()


  • Stationary gamma camera system

NA - 08800048410296

TLIF Bone Packing Block
Medyssey Co., Ltd.
NTPB-001
In Commercial Distribution

  • 08800048410296 ()


  • Bone graft packing block

NA - 08800048404127

Packing Block(C7)
Medyssey Co., Ltd.
N7PB-001
In Commercial Distribution

  • 08800048404127 ()


  • Bone graft packing block

NA - 08800048402215

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

  • 08800048402215 ()


  • Bone graft packing block

NA - 08800042415952

Platform
Medyssey Co., Ltd.
NAPF-001
In Commercial Distribution

  • 08800042415952 ()


  • Bone graft packing block

MediSourceNet, Inc - 00850034735160

KWV-StarterKit, Smoke Evacuation starter Kit. Includes Smoke Evacaution unit, Filter and Detecto.
Medisourcenet, Inc
KWV-StarterKit
In Commercial Distribution

  • 00850034735160 ()


  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735030

KWV-LT : KwikVac Liquid Trap / 20pcs in one box
Medisourcenet, Inc
KWV-LT
In Commercial Distribution

  • 00850034735030 ()


  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735023

KWV-F : KwikVac Smoke Evacuation Filter / 1 each
Medisourcenet, Inc
KWV-F
In Commercial Distribution

  • 00850034735023 ()
  • 10850034735020 ()


  • Surgical plume evacuation system
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