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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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CIONIC iOS Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000030 ()
62000003

  • Gait-enhancement electrical stimulation system, external
An electrically-powered, mobile assembly of devices designed to enable one person to lift and move an incapacitated patient or a person with a disability safely and with minimal physical effort. Also known as a patient hoist, it typically consists of a support base on wheels with a motorized lifting mechanism, mast, boom/lifting arm(s), swivel bar, a patient holding device (e.g., a sling, holder or a frame). It is typically used to lift and move the occupant in a sitting or semi-sitting position over short distances within the treatment facility, e.g., from a bed to a bathroom.
Garaventa (Canada) Ltd.
10
In Commercial Distribution

  • B24010 ()


  • Stairlift, chair
Dental surgery treatment planning software
Dental Wings GmbH
10
In Commercial Distribution

  • D835CODX200 ()
  • D835CODX1 ()
  • D835CODX201 ()
  • D835CODX202 ()


  • Diagnostic x-ray digital imaging system workstation
Humeral Spacer Connector 20 Connection D: 10 TiAl6V4 ELI sterile
Merete GmbH
10
In Commercial Distribution

  • 04048266179890 ()

  • Outer Diameter: 10 Millimeter
GB61001S

  • Diaphysis prosthesis
No Description
Merete GmbH
10
In Commercial Distribution

  • 04048266131812 ()

  • step: 10 mm
FH14010

  • Orthopaedic fixation plate, non-bioabsorbable
Mojo Medical Bags are equipped with MARCH Medical Gear in our simplified, color-coded treatment system linking icon identifiers to a treatment category within the MARCH protocol. MASSIVE HEMORRHAGE AIRWAY RESPIRATION CIRCULATION HEAD & HYPOTHERMIA
Safeguard US Operating, LLC
10
Not in Commercial Distribution

  • M6898444601100 ()
84-446-01

  • First aid kit, non-medicated, single-use
The transfusion of fresh whole blood is the best option for management of casualties with hemorrhagic shock. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from shock due to hemorrhage. Pre-screening to identify Type O Low Titer Donors in the operational forces is the next evolution in forward fresh whole blood resuscitation. This advancement simplifies this task by reducing the steps, supplies and time required to perform this lifesaving intervention. This self contained, low cube set is an affordable and sensible solution for training and equipping organizations that pre-identify their donors.
Safeguard US Operating, LLC
10
In Commercial Distribution

  • M68980875100 ()
80-875

  • Blood transfusion set, non-exchange
ADVANCED LTOWB ADMINISTRATION SET Constricting Band (18" x 1") 1 ea Gauze Sponge 4 ea Safety IV Cath 16G x 1.25" 2 ea Prevahex Transparent Dressing (4" x 4.75") 2 ea IV Set "Y"-Type w-Filter 1 ea Blood Collection Bag 1 ea Gloves (Pair) 1 pr Chlorhexidine Swab 4 ea Kelly Clamp 1 ea Needle Port 2 ea Needleless Port 2 ea Beaded Cable Tie 1 ea Nylon Cord (10") 1 ea ASBP 572 1 ea Blood Bag Label 1 ea Valkyrie TCCC Card 1 ea Instructions for Use 1 ea
Safeguard US Operating, LLC
10
In Commercial Distribution

  • M68980821100 ()
80-821

  • Blood transfusion set, non-exchange
he Fresh Whole Blood Recipient Set contains everything needed to properly document recipient information, screen for ABO/Rh compatibility and transfuse fresh whole blood in a compact sealed package. The transfusion of fresh whole blood is the best option for management of casualties with hemorrhagic shock. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from shock due to hemorrhage.
Safeguard US Operating, LLC
10
In Commercial Distribution

  • M68980801R100 ()
80-801-R

  • Blood transfusion set, non-exchange
The Cravat is a multipurpose triangular shaped textile that can be used to sling and support injuries, immobilize fractures and dislocations, or even bandage wounds.
Safeguard US Operating, LLC
10
In Commercial Distribution

  • M68932600100 ()
32-600

  • Elevation arm sling
Nova 10/10+ Analyzer w/ Printer / Primary Tube Auto Sampler
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 10385480539637 ()
  • 00385480539630 ()
53963

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
NOVA 10 URINE DILUENT
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 00385480161381 ()
16138

  • Buffered sample diluent IVD, manual
NOVA 10 TOTAL CALCIUM SENSOR
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 10385480152799 ()
  • 00385480152792 ()
15279

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
NOVA 10/10+ Analyzer w Printer (w Acc Pack)
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 10385480152126 ()
  • 00385480152129 ()
15212

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
NOVA 10/10+ Analyzer (non dilutor) (no Acc Pack)
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 10385480152119 ()
  • 00385480152112 ()
15211

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
NOVA 10 TUBING HARNESS WITHOUT DILUTOR
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 00385480146173 ()
14617

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
NOVA 10 Na+, K+, Cl-, TCa
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 00385480146081 ()
14608

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
No Description
Ad-Tech Medical Instrument Corporation
10
In Commercial Distribution

  • 00841823109712 ()
BF08R-SP21X-0C3

  • Depth electrode
Nova 10/10+ Analyzer w/ Printer /Dilutor
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 10385480539644 ()
  • 00385480539647 ()
53964

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
NOVA 10 TUBING HARNESS WITH DILUTOR
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 00385480146180 ()
14618

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
NOVA 10 W/R PUMP TUBE WITHOUT DILUTOR
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 00385480131988 ()
13198

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
NOVA 10 W/R PUMP TUBE WITH DILUTOR
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 00385480131971 ()
13197

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
SE CUTTING INST. #10
NORDENT MANUFACTURING INC
10
In Commercial Distribution

  • 00840018633674 ()


  • Margin finishing dental file/rasp, reusable
TECHNO CUT CARBON STEEL STERILE SURGICAL BLADE #10 INDIVIDUALLY PACKED
NIRAJ INDUSTRIES PRIVATE LIMITED
#10
In Commercial Distribution

  • 28904233118104 ()
  • 18904233118107 ()
  • 58904233118105 ()
  • 08904233118100 ()
01810

  • Manual scalpel blade, single-use
STAINLESS STEEL NON STERILE SURGICAL BLADE # 10 BULK PACKED
NIRAJ INDUSTRIES PRIVATE LIMITED
#10
In Commercial Distribution

  • 58904233117979 ()
  • 18904233117971 ()
  • 08904233117974 ()
01797

  • Manual scalpel blade, single-use
TECHNO CUT STAINLESS STEEL STERILE SCALPEL (SURGICAL BLADE WITH PLASTIC HANDLE & COVER) #10 INDIVIDUALLY PACKED MYCO REORDER # 6008T-10
NIRAJ INDUSTRIES PRIVATE LIMITED
#10
In Commercial Distribution

  • 58904233117665 ()
  • 18904233117667 ()
  • 08904233117660 ()
01766

  • Scalpel, single-use
The AnovoTM Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipulation of tissue, using graspers and electrosurgery devices during single-site laparoscopic gynecologic procedures such as benign hysterectomy and salpingo-oophorectomy through a transvaginal access point. The system composed of Anovo Surgeon Console, two sterile instruments (Anovo Instrument ARMS), bed-mounted Robotic Control Unit (RCU) and Anovo System Accessories (Unit cables, Sterile Drapes, Robotic Control Unit Support System (RCUSS) and Vaginal Access Kit). The Anovo Surgeon Console comprised of Arm Controllers (Joysticks and Thumbsticks), an Adjustable Controllers Stand, a PC with Touch Screen, Manual Release Tool and the Power Adapter, and allowing the operating surgeon to operate the Anovo Instrument Arms. There are two sets of Arm Controllers for the Anovo System: two Thumbsticks and two ARMS Controllers. The ARMS Controllers are enabled only when the system is at “resume” state and allow for the accurate control of the Anovo Instrument ARMS during the surgical procedure. Like the Anovo Instrument Arm, each ARMS Controllers has three joints: wrist, elbow and shoulder, so that each Anovo Instrument ARM moves accordingly to Controller's movement. The surgeon-held Controller handle is above the elbow joint and allows for multiple functionality transitions.
MOMENTIS SURGICAL LTD
10
In Commercial Distribution

  • 07290018151013 ()
  • 17290018151010 ()
FP-03-0003

  • Endoscopic electromechanical surgical system
TECHNO CUT PRO STAINLESS STEEL STERILE CARTRIDGE BLADE MANAGEMENT SYSTEM # 10 INDIVIDUALLY PACKED
NIRAJ INDUSTRIES PRIVATE LIMITED
#10
In Commercial Distribution

  • 58904233144715 ()
  • 18904233144717 ()
  • 08904233144710 ()
04471

  • Manual scalpel blade, single-use
TECHNO CUT HIGH CARBON STAINLESS STEEL STERILE SURGICAL BLADE # 10 WITH SILICON COATING INDIVIDUALLY PACKED
NIRAJ INDUSTRIES PRIVATE LIMITED
#10
In Commercial Distribution

  • 28904233137402 ()
  • 18904233137405 ()
  • 58904233137403 ()
  • 08904233137408 ()
03740

  • Manual scalpel blade, single-use
STAINLESS STEEL NON STERILE SCALPEL (SURGICAL BLADE WITH PLASTIC HANDLE & COVER) #10 BULK PACKED MYCO REORDER # 6000CST-10
NIRAJ INDUSTRIES PRIVATE LIMITED
#10
In Commercial Distribution

  • 28904233122965 ()
  • 18904233122968 ()
  • 58904233122966 ()
  • 08904233122961 ()
02296

  • Scalpel, single-use
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