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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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Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bone screw used in the Integra® Ti6® Internal Fixation System
Ascension Orthopedics, Inc.
TH2516
In Commercial Distribution

  • 10381780115342 ()
  • M268TH25161 ()

  • 16 mm L x 2.5 mm dia; 7 mm thread
TH2516

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bone screw used in the Integra® Ti6® Internal Fixation System
Ascension Orthopedics, Inc.
TH2514
In Commercial Distribution

  • 10381780115335 ()
  • M268TH25141 ()

  • 14 mm L x 2.5 mm dia; 6 mm thread
TH2514

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bone screw used in the Integra® Ti6® Internal Fixation System
Ascension Orthopedics, Inc.
TH2512
In Commercial Distribution

  • 10381780115328 ()
  • M268TH25121 ()

  • 12 mm L x 2.5 mm dia; 4.85 mm thread
TH2512

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bone screw used in the Integra® Ti6® Internal Fixation System
Ascension Orthopedics, Inc.
TH2510
In Commercial Distribution

  • 10381780115311 ()
  • M268TH25101 ()

  • 10 mm L x 2.5 mm dia; 2.85 mm thread
TH2510

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
With internal/external multi-variable (parameter) steam indicator. Compatible with steam and EO processes. 8 in x 16 in (20 cm x 41 cm)
CROSSTEX INTERNATIONAL, INC.
SCL8162
In Commercial Distribution

  • 50732224109454 ()
  • 10732224109456 ()
  • D682SCL81622L ()
  • 00732224109459 ()
SCL8162

  • Sterilization packaging, single-use
With internal/external multi-variable (parameter) steam indicator. Compatible with steam and EO processes. 3.5 in x 22 in (9 cm x 56 cm)
CROSSTEX INTERNATIONAL, INC.
SCL3222
In Commercial Distribution

  • 50732224109409 ()
  • 10732224109401 ()
  • D682SCL32222B ()
  • 00732224109404 ()
SCL3222

  • Sterilization packaging, single-use
With internal/external multi-variable (parameter) steam indicator. Compatible with steam and EO processes. 10 in x 17 in (27 cm x 43 cm)
CROSSTEX INTERNATIONAL, INC.
SCL10172
In Commercial Distribution

  • 50732224109317 ()
  • 10732224109319 ()
  • D682SCL101722F ()
  • 00732224109312 ()
SCL10172

  • Sterilization packaging, single-use
The !SEN-Goggles are used in the assessment of nystagmus by measuring, recording, displaying, and analyzing eye movements. This device consists of patient eye goggles ("ISEN-Goggles"). They have an adjustable, elastic headband, an LCD display, two green LED lights to provide optional focal points, eight infrared LED lights to provide illumination for the internal cameras, an internal SD-type memory, and buttons to operate the device's function. There is also a micro-USS port to facilitate transfer of data captured and stored in the device's SD-type memory. The patient eye goggles are an opaque, facially worn device fitted with two small video cameras, and two wavelengths of light emitting diodes (LEDs). One set of lights provides illumination for the cameras. The other allows the user to provide a focus point for the patient, if this is desired. These signals are processed by the image processor that allows for near-simultaneous viewing of the video images from both eyes on the attached LCD screen.
ISEN Tech. & Trading Co.,Ltd.
V06
In Commercial Distribution

  • B499V062 ()
  • B499V061 ()
  • B499V060 ()


  • Nystagmus inducing optokinetic drum
  • Nystagmus inducing tape
The cannulated screwdriver axis, with a 6.0mm diameter tri shank attachment, is used to implant the 6.5mm compression screws. It has a specific spanner slotted-like tip with two threads opposite each other designed to fit the screw head.
NEWDEAL
119562ND
Not in Commercial Distribution

  • M248119562ND1 ()
  • 10381780052142 ()

  • 2.7mm inner/8.5mm outer diameter X 110mm length


  • Surgical screwdriver, reusable
physiological signal amplfier
eemagine Medical Imaging Solutions GmbH
EE-511
In Commercial Distribution

  • B195EE511 ()


  • Electroencephalographic signal amplifier
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