Company Name Brand Name GMDN Term 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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Anterior Cervical Plating System, 3 level implant. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-3-62
In Commercial Distribution

  • 90814008023403 ()

  • Height: 62 Millimeter
  • Width: 17 Millimeter
  • Depth: 1.98 Millimeter
ACP-3-62

  • Intervertebral-body internal spinal fixation system
Anterior Cervical Plating System, 2 level implant. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-2-51
In Commercial Distribution

  • 90814008023359 ()

  • Height: 51 Millimeter
  • Width: 17 Millimeter
  • Depth: 1.98 Millimeter


  • Intervertebral-body internal spinal fixation system
Anterior Cervical Plating System, 2 level implant. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-2-33
In Commercial Distribution

  • 90814008023298 ()

  • Height: 33 Millimeter
  • Width: 17 Millimeter
  • Depth: 1.98 Millimeter
ACP-2-33

  • Intervertebral-body internal spinal fixation system
Anterior Cervical Plating System, 1 level implant. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-1-34
In Commercial Distribution

  • 90814008023281 ()

  • Height: 34 Millimeter
  • Width: 17 Millimeter
  • Depth: 1.98 Millimeter
ACP-1-34

  • Intervertebral-body internal spinal fixation system
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 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
Models 400 and 550 Implantable Infusion Pump Refill Kit Contents: (1) 50 ml Calibrated Syringe Barrel (1) Tubing Set with Removable Injection Site (1) Stopcock (2) Huber Point Needles 22 Gauge x 1inch (2.54 cm) (2) Huber Point Needles 22 Gauge x 1.5inch (3.8 cm) (6) Gauze Pads (1) Fenestrated Drape (2) Pump Templates (2) Adhesive Bandages (1) Refill Worksheet (1) Set of INSTRUCTIONS FOR USE
Medos International Sàrl
IP40820US
In Commercial Distribution

  • 10886704078845 ()
IP40820US

  • Implantable intrathecal infusion pump, nonprogrammable
FOR USE WITH CODMAN 3000 series IMPLANTABLE DRUG DELIVERY SYSTEM Contents: (1) 50 ml Calibrated Syringe Barrel (1) Tubing Set (1) Stopcock (2) Huber Point Needles: 22 Gauge x 1.5" (3.8 cm) (6) Gauze Pads (1) Fenestrated Drape (1) Data Sticker (2) Adhesive Bandages (1) Refill Worksheet (1) INSTRUCTIONS FOR USE (2) Instruction Posters
Medos International Sàrl
AP07014US
In Commercial Distribution

  • 10886704078838 ()
AP07014US

  • Implantable intrathecal infusion pump, nonprogrammable
Refill Kit
Medos International Sàrl
91-4287
In Commercial Distribution

  • 10886704072072 ()
914287

  • Implantable intrathecal infusion pump, programmable
Bolus Kit
Medos International Sàrl
91-4284US
In Commercial Distribution

  • 10886704071440 ()
914284US

  • Implantable intrathecal infusion pump, programmable
Refill Kit
Medos International Sàrl
91-4288
In Commercial Distribution

  • 20886704064951 ()
  • 10886704064954 ()
914288

  • Implantable intrathecal infusion pump, programmable
FOR USE WITH CODMAN 3000 series Refill Kit - CODMAN 3000 Series Implantable Drug Delivery System
Medos International Sàrl
AP-07014
In Commercial Distribution

  • 10886704043775 ()
AP07014

  • Implantable intrathecal infusion pump, nonprogrammable
FOR USE WITH: CODMAN 3000 Series Implantable Pump Operating Room Prep Kit Contents: (1) 2.54cm (1 inch) Huber Needle (REF AP-04009) (1) Special Bolus Needle (REF AP-04013-5) (1) Empty Syringe Barrel with Lid assembled to a 33cm (13 inch) Microbore Tubing Set with Clamp Approximate priming volume 0.3mL (3) Instructions for Use Posters
Medos International Sàrl
AP-07004
In Commercial Distribution

  • 10886704043768 ()
AP07004

  • Implantable intrathecal infusion pump, nonprogrammable
Special Bolus Needle for use with CODMAN 3000 series Drug Delivery System Straight Length 2inch (5 cm)
Medos International Sàrl
AP-04032-5
In Commercial Distribution

  • 20886704043741 ()
  • 10886704043744 ()
AP040325

  • Implantable intrathecal infusion pump, nonprogrammable
Non-coring (Huber) Needle for use with CODMAN 3000 Series Drug Delivery System
Medos International Sàrl
AP-04030
In Commercial Distribution

  • 20886704043734 ()
  • 10886704043737 ()
AP04030

  • Implantable intrathecal infusion pump, nonprogrammable
Special Bolus Needle for use with CODMAN 3000 series Drug Delivery System Straight Length 1 3/8inch (3.5 cm)
Medos International Sàrl
AP-04013-5
In Commercial Distribution

  • 20886704043727 ()
  • 10886704043720 ()
AP040135

  • Implantable intrathecal infusion pump, nonprogrammable
Non-coring (Huber) Needle for use with CODMAN 3000 Series Drug Delivery System
Medos International Sàrl
AP-04011
In Commercial Distribution

  • 20886704043710 ()
  • 10886704043713 ()
AP04011

  • Implantable intrathecal infusion pump, nonprogrammable
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
The ReoAmbulator model is 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 ReoAmbulator 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
B
In Commercial Distribution

  • 07290017844305 ()
RA01-0000-00

  • Gait rehabilitation system harness
Zip Pen Extension Nozzle 5.2" (13.2 cm)
MEGADYNE MEDICAL PRODUCTS, INC.
2560J
In Commercial Distribution

  • 30614559105751 ()
  • 10614559105757 ()
  • 50614559105755 ()


  • Surgical plume evacuation system
Tube Adapter
MEGADYNE MEDICAL PRODUCTS, INC.
2151J
In Commercial Distribution

  • 30614559105737 ()
  • 10614559105733 ()


  • Surgical plume evacuation system
MEGADYNE ACE BLADE 700, 2.5" Modified Blade, PTFE Coated, ZIP Pen Smoke Evacuation Pencil, E Connector, 10 Ft (3.04m) Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
ME725M1E
In Commercial Distribution

  • 30614559105676 ()
  • 10614559105672 ()


  • Surgical plume evacuation system
MEGADYNE ACE BLADE 700, 2.5" Standard Blade, PTFE Coated, ZIP Pen Smoke Evacuation Pencil, E Connector, 10 Ft (3.04m) Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
ME7251E
In Commercial Distribution

  • 30614559105669 ()
  • 10614559105665 ()


  • Surgical plume evacuation system
MEGADYNE ACE BLADE 700, 2.5" Modified Blade, PTFE Coated, ZIP Pen Smoke Evacuation Pencil, C Connector, 10 Ft (3.04m) Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
ME725M1C
In Commercial Distribution

  • 30614559105652 ()
  • 10614559105658 ()


  • Surgical plume evacuation system
MEGADYNE ACE BLADE 700, 2.5" Standard Blade, PTFE Coated, ZIP Pen Smoke Evacuation Pencil, C Connector, 10 Ft (3.04m) Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
ME7251C
In Commercial Distribution

  • 30614559105645 ()
  • 10614559105641 ()


  • Surgical plume evacuation system
Connector Smoke Evacuator Universal Non-sterile
MEGADYNE MEDICAL PRODUCTS, INC.
2150J
In Commercial Distribution

  • 10614559105405 ()
  • 30614559105409 ()


  • Surgical plume evacuation system
Connector 22mm ID Filter to Tubing Non-sterile
MEGADYNE MEDICAL PRODUCTS, INC.
2145J
In Commercial Distribution

  • 10614559105399 ()
  • 30614559105393 ()


  • Surgical plume evacuation system
Mega Vac Connector Filter to Tubing Non-sterile
MEGADYNE MEDICAL PRODUCTS, INC.
2140J
In Commercial Distribution

  • 10614559105382 ()
  • 30614559105386 ()


  • Surgical plume evacuation system
ZIP Pen Ergonomic Smoke Evacuation Pencil E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tubing, 22mm Connector
MEGADYNE MEDICAL PRODUCTS, INC.
252510EC
In Commercial Distribution

  • 30614559105348 ()
  • 10614559105344 ()


  • Surgical plume evacuation system
Zip Pen Extension Nozzle 2.7" (6.8 cm)
MEGADYNE MEDICAL PRODUCTS, INC.
2540J
In Commercial Distribution

  • 30614559105324 ()
  • 10614559105320 ()
  • 50614559105328 ()


  • Surgical plume evacuation system
ZIP Pen Ergonomic Smoke Evacuation Pencil, E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
252510ECBN
Not in Commercial Distribution

  • 30614559105119 ()
  • 10614559105115 ()


  • Surgical plume evacuation system
ZIP Pen Ergonomic Smoke Evacuation Pencil, E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
252510BN
Not in Commercial Distribution

  • 30614559105102 ()
  • 10614559105108 ()


  • Surgical plume evacuation system
Megadyne Smoke Evacuator Connect Cable, 2.1m
MEGADYNE MEDICAL PRODUCTS, INC.
2406J
In Commercial Distribution

  • 10614559104668 ()
  • 30614559104662 ()


  • Surgical plume evacuation system
Megadyne Smoke Evacuator Connect Cable, 1m
MEGADYNE MEDICAL PRODUCTS, INC.
2403J
In Commercial Distribution

  • 10614559104651 ()
  • 30614559104655 ()


  • Surgical plume evacuation system
Megadyne Smoke Evacuator RF Sensor
MEGADYNE MEDICAL PRODUCTS, INC.
2255J
In Commercial Distribution

  • 30614559104648 ()
  • 10614559104644 ()
  • 50614559104642 ()


  • Surgical plume evacuation system
Megadyne Speculum Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
2395J
In Commercial Distribution

  • 30614559104600 ()
  • 10614559104606 ()


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

  • 30614559104594 ()
  • 10614559104590 ()


  • Surgical plume evacuation system
Megadyne Smoke Evacuator
MEGADYNE MEDICAL PRODUCTS, INC.
MESE1
In Commercial Distribution

  • 10614559104545 ()


  • Surgical plume evacuation system
Connector, Smoke Evacuator to Tubing, 22mm I.D., non-sterile
MEGADYNE MEDICAL PRODUCTS, INC.
2155
In Commercial Distribution

  • 10614559102060 ()


  • Surgical plume evacuation system
E-Z LINK
MEGADYNE MEDICAL PRODUCTS, INC.
MGEZLINK01
In Commercial Distribution

  • 10614559104460 ()


  • Surgical plume evacuation system
Mini Vac Surgical Smoke Evacuator 220v
MEGADYNE MEDICAL PRODUCTS, INC.
ECVV220
In Commercial Distribution

  • 10614559104439 ()


  • Surgical plume evacuation system
Mini Vac Surgical Smoke Evacuator 120v
MEGADYNE MEDICAL PRODUCTS, INC.
ECVV120
In Commercial Distribution

  • 10614559104422 ()
  • 30614559104426 ()


  • Surgical plume evacuation system
PUMP 8637-40 SYNCHMED II 40ML EMAN SYMBL
MEDTRONIC, INC.
8637-40
In Commercial Distribution

  • 00643169630512 ()

  • Reservoir Volume 40 mL


  • Implantable intrathecal infusion pump, programmable
PUMP 8637-20 SYNCHMED II 20ML EMAN SYMBL
MEDTRONIC, INC.
8637-20
In Commercial Distribution

  • 00643169630505 ()

  • Reservoir Volume 20 mL


  • Implantable intrathecal infusion pump, programmable
PUMP 8637-40 SYNCHMED II 40ML DLC MOTOR
MEDTRONIC, INC.
8637-40
In Commercial Distribution

  • 00643169530126 ()

  • Total Volume: 40.0 Milliliter


  • Implantable intrathecal infusion pump, programmable
PUMP 8637-40 SYNCHROMED II 40ML DLC US
MEDTRONIC, INC.
8637-40
In Commercial Distribution

  • 00643169984226 ()

  • Total Volume: 40.0 Milliliter


  • Implantable intrathecal infusion pump, programmable
PUMP 8637-20 SYNCHROMED II 20ML DLC US
MEDTRONIC, INC.
8637-20
In Commercial Distribution

  • 00643169984219 ()

  • Total Volume: 20.0 Milliliter


  • Implantable intrathecal infusion pump, programmable
STATION EX0220045 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0220045
In Commercial Distribution

  • 00763000371777 ()


  • Bone graft packing block
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