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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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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 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
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 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
The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual control during the dilation • the tension on the tissue is visible while passing the stricture, thereby avoiding overstretching • reduced procedure time due to less intrument change • evaluation can be done directly after the dilation thanks to the attached transparent cap • two lateral holes for air insufflation and suction • one centered hole for the insertion of a guide wire
Ovesco Endoscopy AG
10
Not in Commercial Distribution

  • 04260206310839 ()
  • 04260206310846 ()

  • mounting depht of the cap: 5 mm
  • for endoscopes with diameter 5.5 - 6 mm
  • Length: 20.6 Millimeter
  • Outer Diameter: 10.1 Millimeter
400.31.03

  • Endoscopic gastrointestinal stenosis dilator
TIDI Positioning Aid Kits Kit, Various Sizes 6 per Set
TIDI PRODUCTS, LLC
10
Not in Commercial Distribution

  • 00618125168248 ()


  • Multifunction body cushion
The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the female breast. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis. The included Breast Biopsy Unit permits MR guided breast biopsy and placement of localization-wire by a trained physician.
Noras MRI products GmbH
10
In Commercial Distribution

  • 04251269207389 ()
118890

  • MRI system coil, radio-frequency
KIATO PLUS Sterile Carbon Steel Rib Back Surgical Blade Box of 100 size 10. Sterilized by Gamma irradiation
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
10
In Commercial Distribution

  • 28902895182105 ()
  • 08902895182101 ()
18210

  • Manual scalpel blade, single-use
KIATO PLUS Sterile Stainless Steel Surgical Blade box of 100 size 10. Sterilized by Gamma Irradiation
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
10
In Commercial Distribution

  • 28902895181108 ()
  • 08902895181104 ()
18189

  • Manual scalpel blade, single-use
KIATO PLUS Sterile Carbon steel Surgical Blade box of 100 size 10. Sterilized by Gamma irradiation.
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
10
In Commercial Distribution

  • 28902895180101 ()
  • 08902895180107 ()
18010

  • Manual scalpel blade, single-use
Kiato Sterile Disposable scalpel Stainless Steel box of 10 size 10. Sterilized using ethylene oxide.
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
10
In Commercial Distribution

  • 28902895148101 ()
  • 08902895148107 ()
14810

  • Scalpel, single-use
KIATO Plus Sterile Safety Scalpel Stainless Steel Box of 10 size 10. Sterilized using ethylene oxide.
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
10
In Commercial Distribution

  • 28902895129100 ()
  • 08902895129106 ()
12910

  • Scalpel, single-use
KIATO Sterile CE carbon Steel Surgical Blade Box of 100 size 10. Sterilized by Gamma Irradiation.
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
10
In Commercial Distribution

  • 08902895111101 ()
  • 28902895111105 ()
11110

  • Manual scalpel blade, single-use
No Description
DEXIS LLC
10
In Commercial Distribution

  • EKAV100879340 ()
1.008.7934

  • Radiology information system application software
The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
Ulab Systems, Inc.
10
In Commercial Distribution

  • 00860461001776 ()
FG0064

  • Dental milling system, CAD/CAM, laboratory
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
Humeral Spacer Connector 20 Connection D: 10 TiAl6V4 ELI sterile
Merete GmbH
10
In Commercial Distribution

  • 04048266179890 ()

  • Outer Diameter: 10 Millimeter
GB61001S

  • Diaphysis prosthesis
CIONIC Android Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000040 ()
62000004

  • Gait-enhancement electrical stimulation system, external
CIONIC iOS Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000030 ()
62000003

  • Gait-enhancement electrical stimulation system, external
The PureWay® Sharps Collector container is blow molded with High Density Polyethylene plastic. The containers are identical except for capacity. The device has a circular opening at the top with an insert to prevent hand access and items from falling out. The insert is made of Low Density Polyethylene plastic, is also circular limiting the opening to 1.25 inches. The opening allows for a vertical sharps drop. Once the PureWay® Sharps Collector container is full, the cap is placed on top of the opening and screwed close for a tight seal. The containers are designed to contain and hold sharps such as angio-caths, blood needles, lancets, cap needles, and various sized syringes. The shape of the container will be rectangular and the only access to the container is through the screw top opening or aperture. In summary, all PureWay® Sharps Collector containers are blow molded using High Density Polyethylene plastic, non-sterile, disposable, sharps containers (infectious waste container). All the devices allow for onehanded disposal of sharps and offer a means of closure. 2 gallon four pack sharps disposal ship back system (Includes four 2 gallon sharps container, box, bag, zip tie).
PUREWAY COMPLIANCE
10
In Commercial Distribution

  • 10853022008076 ()
  • 00853022008062 ()

  • Total Volume: 2.0 Gallon
40042

  • Sharps container
SE CUTTING INST. #10
NORDENT MANUFACTURING INC
10
In Commercial Distribution

  • 00840018633674 ()


  • Margin finishing dental file/rasp, reusable
Sample collection kit
Biodesix, Inc.
10
In Commercial Distribution

  • G292510 ()
51

  • Blood collection set, invasive
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
SyMRI is a post-processing software medical device intended for use in visualization of the brain. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from a multi-delay, multi-echo acquisition (MDME) to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI can generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast adjustment. SyMRI is indicated for head imaging. When interpreted by a trained physician, SyMRI images can provide information useful in determining diagnosis. SyMRI should always be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR).
SyntheticMR AB (publ)
10
In Commercial Distribution

  • 07340024700023 ()


  • MRI system application software
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
GLASS VAN STAINLESS STEEL STERILE SURGICAL BLADE #10 INDIVIDUALLY PACKED MYCO REORDER # 3001T-10
NIRAJ INDUSTRIES PRIVATE LIMITED
#10
In Commercial Distribution

  • 28904233118340 ()
  • 18904233118343 ()
  • 58904233118341 ()
  • 08904233118346 ()
01834

  • Manual scalpel blade, single-use
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