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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Aligner Chewies Mint Scented
Gc Orthodontics America Inc.
55-0160-0001
In Commercial Distribution

  • D78855016000010 ()
  • D78855016000011 ()
55-0160-0001

  • Orthodontic aligner/retainer seater, single-use
Etchant is 37% phosphoric acid (H3PO4) polymer-thickened for use on enamel to prepare the surface for bonding. 23g bottle of liquid etch with cherry scent
RELIANCE ORTHODONTIC PRODUCTS INC
EL24C
In Commercial Distribution

  • D798EL24C0 ()
EL24C

  • Dental etching solution
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 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
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.
SNSD
Not in Commercial Distribution

  • G051SNSD0 ()


  • Olfactory test stick
The Quick Smell Identification Test or Q-SIT® is a rapid assessment of smell ability for bedside/medical applications. The Q-SIT® comes in convenient booklets of 20 pages. Each page has a tear-off portion for presentation to the patient. The tear-off portion contains three microencapsulated odorants with the standard 4-choice identification options. If the patient misses one or more items, testing with Sensonics International’s 40-item Smell Identification Test is suggested in order to assess the degree of smell loss.
Sensonics, Inc.
QSIT
In Commercial Distribution

  • G051QSIT0 ()


  • Olfactory test stick
The Pocket Smell Tests provide a quick 3-, 4-, 6-, or 8-odor forced-choice screening test using the same microencapsulated odorant technology as the Smell Identification Test. It is a very brief screen for gross olfactory dysfunction. If the test subject misses one or more of the test items, then the 40-item Smell Identification Test™ should be given to accurately quantify the degree of smell loss.
Sensonics, Inc.
PSIT
In Commercial Distribution

  • G051PSIT9 ()


  • Olfactory test stick
A research tool for screening cognitive confounds. This 40-item test is equivalent to the SIT™ except that pictures, rather than odors, are used as stimuli. Provides a control, in experimental settings, for non-olfactory components of the SIT. Can be used multiple times.
Sensonics, Inc.
PIT
In Commercial Distribution

  • G051PIT0 ()
PIT

  • Olfactory test stick
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