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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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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 - 10886704043775

FOR USE WITH CODMAN 3000 series Refill Kit - CODMAN 3000 Series Implantable Drug Delivery System
Medos International Sàrl
AP-07014
Not in Commercial Distribution

  • 10886704043775 ()
AP07014

  • Implantable intrathecal infusion pump, nonprogrammable

NA - 10886704043768

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
Not in Commercial Distribution

  • 10886704043768 ()
AP07004

  • Implantable intrathecal infusion pump, nonprogrammable

NA - 10886704043744

Special Bolus Needle for use with CODMAN 3000 series Drug Delivery System Straight Length 2inch (5 cm)
Medos International Sàrl
AP-04032-5
Not in Commercial Distribution

  • 20886704043741 ()
  • 10886704043744 ()
AP040325

  • Implantable intrathecal infusion pump, nonprogrammable

NA - 10886704043737

Non-coring (Huber) Needle for use with CODMAN 3000 Series Drug Delivery System
Medos International Sàrl
AP-04030
Not in Commercial Distribution

  • 20886704043734 ()
  • 10886704043737 ()
AP04030

  • Implantable intrathecal infusion pump, nonprogrammable

NA - 10886704043720

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
Not in Commercial Distribution

  • 20886704043727 ()
  • 10886704043720 ()
AP040135

  • Implantable intrathecal infusion pump, nonprogrammable

NA - 10886704043713

Non-coring (Huber) Needle for use with CODMAN 3000 Series Drug Delivery System
Medos International Sàrl
AP-04011
Not in Commercial Distribution

  • 20886704043710 ()
  • 10886704043713 ()
AP04011

  • Implantable intrathecal infusion pump, nonprogrammable

NA - 10886704078845

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
Not in Commercial Distribution

  • 10886704078845 ()
IP40820US

  • Implantable intrathecal infusion pump, nonprogrammable

NA - 10886704078838

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
Not in Commercial Distribution

  • 10886704078838 ()
AP07014US

  • Implantable intrathecal infusion pump, nonprogrammable

MEDSTREAM - 10886704072072

Refill Kit
Medos International Sàrl
91-4287
In Commercial Distribution

  • 10886704072072 ()
914287

  • Implantable intrathecal infusion pump, programmable

NA - 10886704071440

Bolus Kit
Medos International Sàrl
91-4284US
In Commercial Distribution

  • 10886704071440 ()
914284US

  • Implantable intrathecal infusion pump, programmable

MEDSTREAM - 10886704064954

Refill Kit
Medos International Sàrl
91-4288
In Commercial Distribution

  • 20886704064951 ()
  • 10886704064954 ()
914288

  • Implantable intrathecal infusion pump, programmable

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 - 00850034735139

WELF-5 : WelFit Adaptor for ESU Pencils and Hyfrecators, 15' hose (1pc)
Medisourcenet, Inc
WELF-5
In Commercial Distribution

  • 10850034735136 ()
  • 00850034735139 ()


  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735122

WELF - WelFit Adaptor for ESU Pencils and Hyfrecators, 10' hose (1pc)
Medisourcenet, Inc
WELF
In Commercial Distribution

  • 10850034735129 ()
  • 00850034735122 ()


  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735115

EXTLI-5 : Extendable Smoke Evacuation Pencil, Insulated Non-stick Ceramic Coated Blade, Holster, 15' Hose (1pc)
Medisourcenet, Inc
EXTLI-5
In Commercial Distribution

  • 10850034735112 ()
  • 00850034735115 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735108

EXTL-5 : Extendable Smoke Evacuation Pencil, Non-stick Ceramic Coated Blade, Holster, 15' Hose (1pc)
Medisourcenet, Inc
EXTL-5
In Commercial Distribution

  • 10850034735105 ()
  • 00850034735108 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735092

EXTLI - Extendable Smoke Evacuation Pencil, Insulated Non-stick Ceramic Coated Blade, Holster, 10' Hose (1pc)
Medisourcenet, Inc
EXTLI
In Commercial Distribution

  • 10850034735099 ()
  • 00850034735092 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735085

EXTL - Extendable Smoke Evacuation Pencil, Non-stick Ceramic Coated Blade, Holster, 10' Hose (1pc)
Medisourcenet, Inc
EXTL
In Commercial Distribution

  • 10850034735082 ()
  • 00850034735085 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735078

REGL-5 : Regular Non-Extendable Smoke Evacuation Pencil, Non-stick Ceramic Coated Blade, Holster, 15' Hose (1pc)
Medisourcenet, Inc
REGL-5
In Commercial Distribution

  • 10850034735075 ()
  • 00850034735078 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735061

REGLI-5 : Regular Non-Extendable Smoke Evacuation Pencil, Insulated Non-stick Ceramic Coated Blade, Holster, 15' Hose (1pc)
Medisourcenet, Inc
REGLI-5
In Commercial Distribution

  • 10850034735068 ()
  • 00850034735061 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735054

REGLI - Regular Non-Extendable Smoke Evacuation Pencil, Insulated Non-stick Ceramic Coated Blade, Holster, 10' Hose (1pc)
Medisourcenet, Inc
REGLI
In Commercial Distribution

  • 10850034735051 ()
  • 00850034735054 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735047

REGL - Regular Non-Extendable Smoke Evacuation Pencil, Non-stick Ceramic Coated Blade, Holster, 10' Hose (1pc)
Medisourcenet, Inc
REGL
In Commercial Distribution

  • 10850034735044 ()
  • 00850034735047 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • 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

MediSourceNet, Inc - 00850034735016

KWV-DT : KwikVac Detecto, Automatic Activation Device / 1 each
Medisourcenet, Inc
KWV-DT
In Commercial Distribution

  • 00850034735016 ()


  • Surgical plume evacuation system

MediSourceNet, Inc - 00850034735009

KWV-M : KwikVac Smoke Evacuation Unit - Each / 1 per Box / Smoke Evacuation Unit (1pc)
Medisourcenet, Inc
KWV-M
In Commercial Distribution

  • 00850034735009 ()


  • Surgical plume evacuation system

Optimal-G - 07290017844312

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

ReoAmbulator - 07290017844305

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

KODIAK PL TL GRAFT BLOCK - 00819824028691

The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The Kodiak Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transformational (TLIF) approach. The implants have a central endplate window to permit packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces, and lateral windows for radiographic visualization. The implants are additively manufactured from Ti-6Al-4V ELI and are available in a variety of heights, footprints, and lordotic configurations to suit individual patient anatomy.
MET 1 TECHNOLOGIES, LLC
04-07G
In Commercial Distribution

  • 00819824028691 ()
04-07G

  • Bone graft packing block

ZIP Pen - 10614559105757

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

  • 10614559105757 ()
  • 50614559105755 ()
  • 30614559105751 ()
2560J

  • Surgical plume evacuation system

Megadyne - 10614559105733

Tube Adapter
MEGADYNE MEDICAL PRODUCTS, INC.
2151J
In Commercial Distribution

  • 10614559105733 ()
  • 30614559105737 ()
2151J

  • Surgical plume evacuation system

Megadyne - 10614559105672

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

  • 10614559105672 ()
  • 30614559105676 ()
ME725M1E

  • Surgical plume evacuation system

Megadyne - 10614559105665

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

  • 10614559105665 ()
  • 30614559105669 ()
ME7251E

  • Surgical plume evacuation system

Megadyne - 10614559105658

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

  • 10614559105658 ()
  • 30614559105652 ()
ME725M1C

  • Surgical plume evacuation system

Megadyne - 10614559105641

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

  • 10614559105641 ()
  • 30614559105645 ()
ME7251C

  • Surgical plume evacuation system

Megadyne - 10614559105405

Connector Smoke Evacuator Universal Non-sterile
MEGADYNE MEDICAL PRODUCTS, INC.
2150J
In Commercial Distribution

  • 10614559105405 ()
  • 30614559105409 ()
2150J

  • Surgical plume evacuation system

Megadyne - 10614559105399

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

  • 10614559105399 ()
  • 30614559105393 ()
2145J

  • Surgical plume evacuation system

Megadyne - 10614559105382

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

  • 10614559105382 ()
  • 30614559105386 ()
2140J

  • Surgical plume evacuation system

ZIP Pen - 10614559105344

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

  • 10614559105344 ()
  • 30614559105348 ()
252510EC

  • Surgical plume evacuation system

ZIP Pen - 10614559105320

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

  • 10614559105320 ()
  • 30614559105324 ()
  • 50614559105328 ()
2540J

  • Surgical plume evacuation system

MEGADYNE - 10614559105115

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

MEGADYNE - 10614559105108

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 - 10614559104668

Megadyne Smoke Evacuator Connect Cable, 2.1m
MEGADYNE MEDICAL PRODUCTS, INC.
2406J
In Commercial Distribution

  • 10614559104668 ()
  • 30614559104662 ()
2406J

  • Surgical plume evacuation system

MEGADYNE - 10614559104651

Megadyne Smoke Evacuator Connect Cable, 1m
MEGADYNE MEDICAL PRODUCTS, INC.
2403J
In Commercial Distribution

  • 10614559104651 ()
  • 30614559104655 ()
2403J

  • Surgical plume evacuation system

MEGADYNE - 10614559104644

Megadyne Smoke Evacuator RF Sensor
MEGADYNE MEDICAL PRODUCTS, INC.
2255J
In Commercial Distribution

  • 10614559104644 ()
  • 30614559104648 ()
  • 50614559104642 ()
2255J

  • Surgical plume evacuation system

SPECULUM TUBING - 10614559104606

Megadyne Speculum Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
2395J
In Commercial Distribution

  • 10614559104606 ()
  • 30614559104600 ()
2395J

  • Surgical plume evacuation system

LAPAROSCOPIC TUBING - 10614559104590

Megadyne Laparoscopic Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
2390J
In Commercial Distribution

  • 10614559104590 ()
  • 30614559104594 ()
2390J

  • Surgical plume evacuation system
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