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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CLEAR GUIDE MEDICAL, INC.
CGSCENERGY
In Commercial Distribution

  • B201CGSCENERGY1 ()
  • B201CGSCENERGY0 ()


  • Ultrasound imaging system application software
  • Stereotactic system application software
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally.
CLEAR GUIDE MEDICAL, INC.
CGCORE24MR
In Commercial Distribution

  • B201CGCORE24MR0 ()
  • B201CGCORE24MR1 ()
CG-CORE24-MR

  • Stereotactic surgery system workstation
  • Ultrasound imaging system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24 model is a panel PC with a 24" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE24
In Commercial Distribution

  • B201CGCORE240 ()
  • B201CGCORE241 ()
CG-CORE24

  • Ultrasound imaging system workstation
  • Stereotactic surgery system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE17 model is a panel PC with a 17" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE17
In Commercial Distribution

  • B201CGCORE170 ()
  • B201CGCORE171 ()
CG-CORE17

  • Ultrasound imaging system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE13 model is a tablet PC with a 13" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE13
In Commercial Distribution

  • B201CGCORE130 ()
  • B201CGCORE131 ()
CG-CORE-13

  • Ultrasound imaging system workstation
  • Stereotactic surgery system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Portable computer
PRO DIA KOT PURE REG 12X50
KIMBERLY CLARK COLOMBIA HOLDING LTDA
Liner
In Commercial Distribution

  • 17702425810867 ()
  • 07702425810860 ()
  • 07441008100232 ()


  • Menstrual pad, unscented
PRO DIA KOT PURE REG 12X120
KIMBERLY CLARK COLOMBIA HOLDING LTDA
Liner
In Commercial Distribution

  • 17702425810850 ()
  • 07702425810853 ()
  • 07441008100232 ()


  • Menstrual pad, unscented
The Snap & Sniff® threshold test system was developed to provide scientists, clinicians, and others with a standardized, easy-to- use, and reliable means for assessing odor detection thresholds. In its standard form, the test employs the odorant phenyl ethyl alcohol (PEA), a stimulus with a rose-like smell at higher concentrations and little or no intranasal trigeminal nerve (CN V) reactivity. Other odorants, including n- butanol, ethyl acetate, guaiacol, pentyl (amyl) acetate, and phenyl ethyl methyl ethyl carbinol, are also available from Sensonics on a custom basis. The Snap & Sniff® threshold test kit is comprised of 20 smell “wands”. Five of these wands contain no odor, whereas the other wands contain, in the case of the standard odorant phenyl ethyl alcohol, half-log stimulus dilutions ranging from 10-2 (strongest) to 10-9 (weakest) concentrations. The odor of a given wand is contained within a cartridge similar to that of a felt-tip pen. When the thumb of the operator pushes forward on a slide mechanism, the odorized tip is exposed for sampling and presented to the subject. Releasing the slide retracts the odorized tip back into the wand’s housing. The Snap & Sniff® mechanism results in an easy presentation of an odorant to a subject. Because the odorant tip is presented only briefly, the odor is retained for much longer periods and can be used for testing many more subjects than devices lacking such sophisticated technology.
Sensonics, Inc.
SST
In Commercial Distribution

  • G051SST0 ()


  • Olfactory test stick
The Sensonics’ S&S-D test is a member of Snap & Sniff® Olfactory Testing System. This test, along with the other members of the Snap & Sniff® family, was developed to provide scientists, clinicians, and others with a standardized, easy-to-use, and reliable means for evaluating the ability of subjects to discriminate odors. Detailed instructions are provided in an accompanying manual to minimize variability in test administration. The test employs the following odorants: phenyl ethyl alcohol; anethole; amyl acetate; and guaiacol. Formulated at iso-intensive levels, the wands are presented in groups of 3 and the subject is asked to choose which of the 3 is different. The presentation pattern is intuitive and easy to follow. The Snap & Sniff® Discrimination Test kit is comprised of 20 smell “wands”. The odor of a given wand is contained within a proprietary odor-emitting cartridge. When the thumb of the operator pushes forward on a slide mechanism, the odorized tip is exposed for sampling and presented to the subject. Releasing the slide retracts the odorized tip back into the wand’s housing. The Snap & Sniff® mechanism results in an easy presentation of an odorant to a subject. Because the odorant tip is presented only briefly, the odor is retained for much longer periods and can be used for testing many more subjects than devices lacking such sophisticated technology. Liquids, per se, are not present in the sniff wands.
Sensonics, Inc.
SSOD
In Commercial Distribution

  • G051SSOD0 ()


  • Olfactory test stick
The Snap & Sniff® threshold test system was developed to provide scientists, clinicians, and others with a standardized, easy-to- use, and reliable means for assessing odor detection thresholds. In its standard form, the test employs the odorant phenyl ethyl alcohol (PEA), a stimulus with a rose-like smell at higher concentrations and little or no intranasal trigeminal nerve (CN V) reactivity. Other odorants, including n- butanol, ethyl acetate, guaiacol, pentyl (amyl) acetate, and phenyl ethyl methyl ethyl carbinol, are also available from Sensonics on a custom basis. The Snap & Sniff® threshold test kit is comprised of 20 smell “wands”. Five of these wands contain no odor, whereas the other wands contain, in the case of the standard odorant phenyl ethyl alcohol, half-log stimulus dilutions ranging from 10-2 (strongest) to 10-9 (weakest) concentrations. The odor of a given wand is contained within a cartridge similar to that of a felt-tip pen. When the thumb of the operator pushes forward on a slide mechanism, the odorized tip is exposed for sampling and presented to the subject. Releasing the slide retracts the odorized tip back into the wand’s housing. The Snap & Sniff® mechanism results in an easy presentation of an odorant to a subject. Because the odorant tip is presented only briefly, the odor is retained for much longer periods and can be used for testing many more subjects than devices lacking such sophisticated technology.
Sensonics, Inc.
SNST
Not in Commercial Distribution

  • G051SNST0 ()


  • Olfactory test stick
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