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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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The Integra Total Foot System Universal Forefoot Plate is a 4-hole plate designed to stabilize a variety of arthrodeses and osteotomies.
Ascension Orthopedics, Inc.
2801222
In Commercial Distribution

  • 10381780119418 ()
  • M26828012221 ()

  • 22 mm
2801222

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
A non-sterile sheath designed to fit over most electrosurgical handpieces. Latex-free, 8" long with 7/8" diameter opening. Box of 100.
DERMATOLOGIC LAB AND SUPPLY, INC.
26100
In Commercial Distribution

  • 10609960000272 ()
  • 00609960000275 ()
  • 20609960000279 ()
26100

  • Instrument/equipment drape, single-use, non-sterile
CLAMP, TUBE, URINE COLLECTION, ADJUSTABLE, REUSABLE, WHITE Features: 6 Adjustable Positions to control flow of urine. Maximum Tube Size O.D: 0.46"
UROCARE PRODUCTS, INC.
6999
In Commercial Distribution

  • 20792293069997 ()
  • 00792293069993 ()
  • 10792293069990 ()

  • Width: 0.70 Inch
  • Length: 1.5 Inch
  • Height: 1.00 Inch
  • Weight: 0.01 Pound
6999

  • Wearable adult urine collection bag, open-ended
  • Hand-held urinal, reusable
  • Non-wearable adult urine collection bag, open-ended
  • Open-ended wearable urine collection bag, non-sterile
  • Penis/scrotum wearable urinal
The NIDEK Optical Coherence Tomography RS-3000 Advance is an ophthalmic camera that allows non-invasive and non-contact observation of the shape of the fundus or retina. Fundus surface images (hereafter referred to as SLO image) are captured with the confocal laser scanning using a near-infrared light source with a wavelength of 785 nm. Cross-sectional images of the retina (hereafter referred to as OCT image) are captured with the optical interferometer using an infrared light source with a wavelength of 880 nm. With the images captured using the RS-3000 Advance, the shape and structure of the fundus or retina can be observed, and diseases can be observed. This system is comprised of the main body for capturing images, a computer (hereafter called PC) for storing and analyzing captured images, PC monitor, and an isolation transformer. In addition, the image filing software NAVIS-EX (hereafter referred to as NAVIS-EX) offers the following features: • Image analysis functions such as 3D/map color display or retinal thickness analysis • Networking for data review or analysis on PCs in separate locations
NIDEK CO.,LTD.
RS-3000 Advance
In Commercial Distribution

  • 04987669100516 ()


  • Direct ophthalmoscope, line-powered
An assortment kit containing a combination of uninitiated and pre-initiated laser tips intended for use with Biolase diode lasers only. The tips have the same core diameter of 400 microns and different lenghts. The tips are non-sterile for single use only and require sterilization prior to use.
Biolase, Inc.
Diode Laser Tips - Starter Kit
Not in Commercial Distribution

  • 00647529004005 ()

  • Length: 9 Millimeter
  • Length: 7 Millimeter
  • Length: 4 Millimeter
  • Outer Diameter: 400 Micrometer
6400165

  • General/multiple surgical laser system beam guide, single-use, non-sterile
The Hallu-Lock plate system is a low profile titanium plate dedicated to the first metatarsophalangeal arthrodesis. This system includes Hallu-Lock C plates, Hallu-Lock S plates, screws, and instruments. The system is intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metatarsophalangeal joint.
NEWDEAL
HALULCKIMP
Not in Commercial Distribution

  • 10381780064473 ()
  • M248HALULCKIMP1 ()
HALULCKIMP

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
"For use on the medication port of Baxter VIAFLEX, Baxter INTRAVIA, Baxter AVIVA, and Baxter ALL-IN-ONE EVA containers to provide both visual evidence that medication has been added and tamper evidence once the device is closed. Packaged in Non-Sterile Bag of 100, 3 bags per shipper box"
INTERNATIONAL MEDICAL INDUSTRIES INC.
21-00
In Commercial Distribution

  • B21221002 ()
  • B21221001 ()
  • B21221000 ()
21-00

  • Syringe tip cap
Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 1 sphere per pouch with 3 pouches in another pouch. There are 5 pouch-in-pouches for a total of 15 spheres.
Northern Digital Inc
8800738
In Commercial Distribution

  • 20805832040026 ()
  • 00805832040022 ()
8800738

  • Imaging lesion localization marker, external, single-use
Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 1 sphere per pouch with 1 pouch in another pouch. There are 5 pouch-in-pouches for a total of 5 spheres.
Northern Digital Inc
8800737
In Commercial Distribution

  • 20805832040019 ()
  • 00805832040015 ()
8800737

  • Imaging lesion localization marker, external, single-use
Serim® DISINTEK™ OPA Test Strips are chemical indicators for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in CIDEX® OPA Solution and MetriCide® OPA Plus™ Solution, is above or below the established minimum effective concentration (MEC) of 0.3%.
SERIM RESEARCH CORPORATION
5121
In Commercial Distribution

  • M17451212 ()
  • M17451211 ()
  • M17451210 ()
5121

  • Ortho-phthalaldehyde (OPA) device disinfectant test strip
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