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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Gait Trainer
RIFTON EQUIPMENT
K640
In Commercial Distribution

  • 00858101008278 ()


  • Gait rehabilitation frame, manual
Gait Trainer
RIFTON EQUIPMENT
K630
In Commercial Distribution

  • 00858101008261 ()


  • Gait rehabilitation frame, manual
SafeGait Active 360 system (Model SGA360) is designed to assist a patient with walking/balance impediments to exercise and/or regain normal gait. SafeGait Active 360 system tethers patients with a dedicated harness hanging from a powered pneumatic braking device on the overhead aluminum rails moved by pulling force from the patient. SafeGait Active 360 system reduces clinician’s workload when helping patients to exercise or relearn the gait in a safe 3D environment. SafeGait Active 360 system shall only be operated by trained clinicians, therapists or DIH staff.
DIH TECHNOLOGY INC.
SGA360
In Commercial Distribution

  • 00860012112838 ()


  • Gait rehabilitation frame, electric
SafeGait Active S1000 system (Model SGAS1000) is designed to assist a patient with some impediments in walking/balance to exercise and/or to regain normal gait. SafeGait Active S1000 system tethers patients with a dedicated harness hanging from a powered pneumatic braking device on the overhead steel rails moved by pulling force from the patient. SafeGait Active S1000 system reduces clinician’s workload when helping patients to exercise or relearn the gait in a safe 3D environment. SafeGait Active S1000 system shall only be operated by trained clinicians, therapists or DIH staff.
DIH TECHNOLOGY INC.
SGAS1000
In Commercial Distribution

  • 00860012112821 ()


  • Gait rehabilitation frame, electric
SafeGait 360 system (Model SG360) is a body weight support system designed to assist a patient with a walking/balance disability to regain mobility via exercise and gait training. SafeGait 360 system tethers patients with a dedicated harness hanging from a powered device running on the overhead aluminum rails to offload the patient’s weight to various levels configurable via a computer or a handheld device. SafeGait 360 system reduces clinician’s workload when helping patients to exercise or relearn the gait in a safe 3D environment. SafeGait 360 system shall only be operated by trained clinicians, therapists or DIH staff.
DIH TECHNOLOGY INC.
SG360
In Commercial Distribution

  • 00860012112814 ()


  • Gait rehabilitation frame, electric
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-168
In Commercial Distribution

  • 09348215055967 ()


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

  • 09348215055943 ()


  • 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
111-182-024
In Commercial Distribution

  • 09348215055790 ()


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

  • 09348215055356 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-170
In Commercial Distribution

  • 09348215055974 ()


  • 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
112-212-164
In Commercial Distribution

  • 09348215055936 ()


  • 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
112-212-162
In Commercial Distribution

  • 09348215055912 ()


  • 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
112-212-160
In Commercial Distribution

  • 09348215055899 ()


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

  • 09348215055882 ()


  • Surgical implant template, reusable
Sentinella 102 is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. It provides scintigraphic images of specific parts of the body based on the detection of gamma rays emitted by the radioisotopes injected into patients. Sentinella presents the following modalities: • Sentinella 102 (this record) • Sentinella 102 Horus
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
SENTINELLA 102 HORUS
In Commercial Distribution

  • 08437018413027 ()

  • Height: 185 Centimeter
  • Depth: 77 Centimeter
  • Width: 63 Centimeter
  • Weight: 134 Kilogram
FP-0055

  • Mobile gamma camera system
Sentinella 102 is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. It provides scintigraphic images of specific parts of the body based on the detection of gamma rays emitted by the radioisotopes injected into patients. Sentinella presents the following modalities: • Sentinella 102 (this record) • Sentinella 102 Horus
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
SENTINELLA 102
In Commercial Distribution

  • 08437018413010 ()

  • Height: 185 Centimeter
  • Depth: 77 Centimeter
  • Width: 63 Centimeter
  • Weight: 134 Kilogram
FP-0040

  • Mobile gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
SoloMobile Gamma Camera System
In Commercial Distribution

  • 05711665004009 ()

  • Weight: 252 Kilogram
  • Height: 173 Centimeter
  • Depth: 138 Centimeter
  • Width: 70 Centimeter
9SOL2210

  • Mobile gamma camera system
GammaPro Straight Standard Probe for wireless ionizing radiation detection.
Kubtec
K0018C01
In Commercial Distribution

  • B619GPROSTDPROBE0 ()


  • Mobile gamma camera system
GammaPro Kit with Standard probe, Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0018C02
In Commercial Distribution

  • B619GPROSTDKIT0 ()


  • Mobile gamma camera system
GammaPro Angled Standard Probe used for wireless ionizing radiation detection.
Kubtec
K0021C01
In Commercial Distribution

  • B619GPROSTDANGPROBE0 ()


  • Mobile gamma camera system
GammaPro Laparoscopic Probe used for wireless ionizing radiation detection.
Kubtec
K0020C01
In Commercial Distribution

  • B619GPROLAPPROBE0 ()


  • Mobile gamma camera system
GammaPro Laparoscopic Probe with Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0020C02
In Commercial Distribution

  • B619GPROLAPKIT0 ()


  • Mobile gamma camera system
GammaPro High Sensitivity Probe used for wireless ionizing radiation detection.
Kubtec
K0019C01
In Commercial Distribution

  • B619GPROHISPROBE0 ()


  • Mobile gamma camera system
GammaPro Hi-Sense Probe with Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0019C02
In Commercial Distribution

  • B619GPROHISKIT0 ()


  • Mobile gamma camera system
Table with installed software is used with wireless battery powered probes (different shapes and sizes) to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity.
Kubtec
K0017C01
In Commercial Distribution

  • B619GPROCASETABL2 ()


  • Mobile gamma camera system
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 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 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
Megadyne Speculum Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
2395J
In Commercial Distribution

  • 10614559104606 ()
  • 30614559104600 ()
2395J

  • Surgical plume evacuation system
Megadyne Laparoscopic Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
2390J
In Commercial Distribution

  • 10614559104590 ()
  • 30614559104594 ()
2390J

  • Surgical plume evacuation system
Adaptor For Valleylab Optimum
DEROYAL INDUSTRIES, INC.
88-000696
In Commercial Distribution

  • 50749756237494 ()
  • 00749756237499 ()
88-000696

  • Surgical plume evacuation system
Smoke Evacuation Tubing Support Stand
COASTAL LIFE TECHNOLOGIES, INC.
907001
In Commercial Distribution

  • 00814716020777 ()


  • Surgical plume evacuation system
SMOKE EVACUATOR ARTICULATED, ARMSTAND WITH FASTENERS
BOVIE MEDICAL CORPORATION
SEAS
In Commercial Distribution

  • 10607151065161 ()
SEAS

  • Surgical plume evacuation system
Unit suction cover for the Aegis Air Filtration Unit - A Portable air filtration station to remove particulates and contaminants from the air within an enclosed room or space.
CAO GROUP, INC.
005-00089
In Commercial Distribution

  • 00872320005719 ()


  • Surgical plume evacuation system
Unit filtration cover for the Aegis Air Filtration Unit - A Portable air filtration station to remove particulates and contaminants from the air within an enclosed room or space.
CAO GROUP, INC.
005-00088
In Commercial Distribution

  • 00872320005702 ()


  • Surgical plume evacuation system
Portable air filtration station to remove particulates and contaminants from the air within an enclosed room or space.
CAO GROUP, INC.
005-00087
In Commercial Distribution

  • 00872320005696 ()


  • Surgical plume evacuation system
Replacement small square inlet collector for the Aegis Aerosol VacStation.
CAO GROUP, INC.
005-00086
In Commercial Distribution

  • 00872320005603 ()


  • Surgical plume evacuation system
Replacement primary cotton filter for the Aegis Aerosol VacStation.
CAO GROUP, INC.
005-00046
In Commercial Distribution

  • 00872320005450 ()
  • 00872320005504 ()


  • Surgical plume evacuation system
Replacement inlet collector for the Aegis Aerosol VacStation.
CAO GROUP, INC.
005-00050
In Commercial Distribution

  • 00872320005498 ()


  • Surgical plume evacuation system
Replacement collection tube for the Aegis Aerosol VacStation.
CAO GROUP, INC.
005-00049
In Commercial Distribution

  • 00872320005481 ()


  • Surgical plume evacuation system
Replacement charcoal filter cartridge for the Aegis Aerosol VacStation.
CAO GROUP, INC.
005-00048
In Commercial Distribution

  • 00872320005474 ()


  • Surgical plume evacuation system
Replacement secondary fiberglass filter for the Aegis Aerosol VacStation.
CAO GROUP, INC.
005-00047
In Commercial Distribution

  • 00872320005467 ()


  • Surgical plume evacuation system
Plume vacuum station to provide suction for removing plume, spray, and particulates generated during dental procedures.
CAO GROUP, INC.
005-00045
In Commercial Distribution

  • 00872320004958 ()


  • Surgical plume evacuation system
FREND™ Blocking Reagent is provided in 15 tubes, the blocking reagent is buffer based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The Blocking Reagent is provided in a dried solid state.
NanoEnTek, Inc.
FREND Blocking Reagent
In Commercial Distribution

  • 08809317540825 ()
FRBR 015

  • Immunohistochemistry endogenous protein blocking reagent IVD
DR-HO's Perfect Back Rest This product is used for waist massage.Plastic injection molding into the ""S"" type, the external concave can better wrap the back of the human body, the middle part of the hemispherical origin, when the user by pressure, can be very good reaction force to the back, massage the effect.Products by the back, air cushion, fixed belt combination.
Guangzhou Xinbo Electronic Co., Ltd.
PBR-1
In Commercial Distribution

  • 06970742221473 ()


  • Back-filling orthosis
Awl Small. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-112
In Commercial Distribution

  • 00814008029778 ()


  • General internal orthopaedic fixation system implantation kit
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