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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 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
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
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
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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