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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 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 10/10+ 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
No Description
Ad-Tech Medical Instrument Corporation
10
In Commercial Distribution

  • 00841823109712 ()
BF08R-SP21X-0C3

  • Depth electrode
Sample collection kit
Biodesix, Inc.
10
In Commercial Distribution

  • G292510 ()
51

  • Blood collection set, invasive
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
No Description
Merete GmbH
10
In Commercial Distribution

  • 04048266131812 ()

  • step: 10 mm
FH14010

  • Orthopaedic fixation plate, non-bioabsorbable
Humeral Spacer Connector 20 Connection D: 10 TiAl6V4 ELI sterile
Merete GmbH
10
In Commercial Distribution

  • 04048266179890 ()

  • Outer Diameter: 10 Millimeter
GB61001S

  • Diaphysis prosthesis
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
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