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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Comfort Plus™ Premium Saliva Ejectors, White,Pink Bubble Gum Scented
CROSSTEX INTERNATIONAL, INC.
ZWPCPBG
In Commercial Distribution

  • 50732224000836 ()
  • 10732224000838 ()
  • 00732224000831 ()


  • Dental suction system cannula, single-use
Steering Cloth Electrode, Left
BIONESS INC.
SCE-1100
In Commercial Distribution

  • 00815962020436 ()


  • Transcutaneous electrical stimulation electrode, reusable
Steering Cloth Electrode, Right
BIONESS INC.
SCE-1000
In Commercial Distribution

  • 00815962020429 ()


  • Transcutaneous electrical stimulation electrode, reusable
AS2 Test Template Scenario1
Zimmer, Inc.
CAT0003
In Commercial Distribution

  • Z0000000001 ()
  • ZB200001000 ()

  • Length: 5.5 Feet
CAT0003

  • Spinal fixation plate, non-bioabsorbable
THERAPY WAFER - SCENTED BUBBLE GUM 25PK
DENTSPLY SIRONA ORTHODONTICS INC.
EB-25PBG
In Commercial Distribution

  • D746EB25PBG0 ()
  • D746EB25PBG1 ()
EB-25PBG

  • Bite relief pad
THERAPY WAFER - SCENTED GRAPE 25PK
DENTSPLY SIRONA ORTHODONTICS INC.
EB-25G
In Commercial Distribution

  • D746EB25G0 ()
  • D746EB25G1 ()
EB-25G

  • Bite relief pad
THERAPY WAFER - SCENTED MINT 25PK
DENTSPLY SIRONA ORTHODONTICS INC.
EB-25M
In Commercial Distribution

  • D746EB25M0 ()
  • D746EB25M1 ()
EB-25M

  • Bite relief pad
THERAPY WAFER - SCENTED CHERRY 25PK
DENTSPLY SIRONA ORTHODONTICS INC.
EB25
In Commercial Distribution

  • D746EB250 ()
  • D746EB251 ()
EB25

  • Bite relief pad
Aligner Chewies Watermelon Scented
Gc Orthodontics America Inc.
55-0160-0003
In Commercial Distribution

  • D78855016000030 ()
  • D78855016000031 ()
55-0160-0003

  • Orthodontic aligner/retainer seater, single-use
Aligner Chewies Lemon Scented
Gc Orthodontics America Inc.
55-0160-0002
In Commercial Distribution

  • D78855016000020 ()
  • D78855016000021 ()
55-0160-0002

  • Orthodontic aligner/retainer seater, single-use
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
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 Sensonics 16-item odor identification test is a member of the Snap & Sniff® Olfactory Testing System family. This test, along with the other members of the 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 identify odors. Detailed instructions are provided in an accompanying manual to acquaint the test administrator with the details of proper test administration. The test employs the following familiar odorants: mint, lemon, leather, banana, orange, paint thinner, garlic, licorice, cloves, pineapple, apple, rose, coffee, fish, cinnamon, and chocolate. The S&S-I is comprised of 16 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.
SSI
In Commercial Distribution

  • G051SSI0 ()


  • 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 16-item odor identification test is a member of the Snap & Sniff® Olfactory Testing System family. This test, along with the other members of the 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 identify odors. Detailed instructions are provided in an accompanying manual to acquaint the test administrator with the details of proper test administration. The test employs the following familiar odorants: mint, lemon, leather, banana, orange, paint thinner, garlic, licorice, cloves, pineapple, apple, rose, coffee, fish, cinnamon, and chocolate. The S&S-I is comprised of 16 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.
SNSI
Not in Commercial Distribution

  • G051SNSI0 ()


  • 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
Until the development of the Smell Identification Test™, also known as the University of Pennsylvania Smell Identification Test (UPSIT), no convenient means for subjectively assessing smell function was generally available. By incorporating microencapsulation technology and sound psychometric principles into a simple test format, the Smell Identification Test™ filled this void. Although this test was initially designed to provide only a first-step olfactory “screening” function, it became quite clear early on that the test was much more broadly useful than first envisioned and had applicability in numerous clinical, laboratory, and industrial settings. Indeed, the Smell Identification Test™ was found to be more reliable and to correlate more closely in the clinical setting with patient complaints and other indices of dysfunction than more traditional threshold and suprathreshold psychophysical methods. The Smell Identification Test consists of four envelope-sized booklets, each containing ten “scratch & sniff ” odorants. The odorants are embedded in 10- to 50-um urea-formaldehyde polymer microencap- sules fixed in a proprietary binder and positioned on brown strips at the bottom of the test booklets. The stimuli are released by scratching strips with a pencil tip in a standardized manner. Above each odorant strip is a multiple-choice question with four alternative responses. For example, one of the items reads: “This odor smells most like: a) chocolate; b) banana; c) onion; or d) fruit punch.” The test is forced-choice; i.e., the subject is required to mark one of the four alternatives even if no smell is perceived.
Sensonics, Inc.
SITT
In Commercial Distribution

  • G051SITT0 ()


  • 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 Pediatric Smell Wheel is an attractive game-like test for evaluating olfaction in children. A rotating cardboard disk exposes one of 11 odors at a time for sampling. Multiple-choice alternatives use both words and pictures. When the disk is completely rotated, the child’s answers appear as dark dots in a series of holes in the jacket. The number of dark dots signifies the test score. Can be used as an educational game as well as a smell test. Ideal for classroom education settings.
Sensonics, Inc.
PSW
In Commercial Distribution

  • G051PSW0 ()


  • 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
The OMT provides a subjective assessment of odor discrimination in general and short-term odor memory in particular. This instrument is a 12-item, single-target, four-alternative, forced- choice test with nominal 10-, 30-, and 60-sec delay intervals. However, these delay intervals are not sacrosanct and can be modified by the test user according to his or her interests or needs. The OMT is based on the match-to-sample paradigm. A unique feature of the OMT is the ease of presentation of the stimuli, since the test administrator must simply scratch open a set of micro- encapsulated odors with a pencil for the subject to sample at the appropriate time points. The micro- encapsulated odorants used in this test – banana, peppermint, rose, and peanut -- were chosen to be isointensive so that only the qualitative stimulus dimension is salient. In this test, a target odorant is released by scratching the odorized label, which is then presented to the subject for sampling. After a given delay interval, four microencapsulated odorants (three of which are foils) are similarly released and presented at ~ five second intervals. The subject’s task is to report which odor in the odor response set is the same as the target stimulus. During the delay interval, each subject is required to count aloud backwards by threes from 280 to minimize verbal rehearsal. The odorants used in the test are counter-balanced such that all odorants occur an equal number of times at each delay interval. The order of the delay intervals is the same for each subject and is as follows for the 12 respective items: 10, 30, 30, 60, 10, 60, 60, 30, 60, 30, 10, & 10 sec. The target odors (TO) and the response set choices (RC) for each of these 12 items are as follows (correct response in italics): (1) TO: PEA; RC: EA, PNUT, PEA, MINT; (2) TO: MIN RC: PEA, MINT, EA, PNUT; (3) TO: PNUT; RC: EA, PEA, MINT, PNUT; (4) TO: EA; RC: EA, PNUT, PEA, MINT; (5) TO: MINT; RC: MINT, EA, PEA, PNUT; (6) TO: PEA; RC: EA, PE
Sensonics, Inc.
ODMT
In Commercial Distribution

  • G051ODMT0 ()


  • Olfactory test stick
The B-SIT is a brief 12-item self-administered microencapsulated odorant test for evaluating olfactory function. It is contained in a single booklet, unlike the 4-booklet UPSIT, and is applicable in any industrial, clinical, or survey setting where a rapid, yet reliable, assessment of olfactory function is required. As with the case of the UPSIT, the odorants are embedded in 10-50 µm urea-formaldehyde polymer micro-capsules fixed in a proprietary binder and positioned on scent strips at the bottom of the pages of the test booklet. The stimuli are released by scratching the strips with a pencil tip in a standardized manner. Above each odorant strip is a multiple-choice question with four alternative responses. For example, one of the items reads: “This odor smells most like: a) motor oil; b) garlic; c) rose; or d) lemon. The subject is required to mark one of the four alternatives even if no smell sensation is perceived (i.e., the test is forced-choice).
Sensonics, Inc.
BSIT
In Commercial Distribution

  • G051BSIT9 ()


  • Olfactory test stick
BED - SCE+ Hosp -Scale, E CPR, Exit Alarm, Elec Brake- 84x35 (Gray)
Hoffmann NOA Medical Industries, LLC
1055044GRY
In Commercial Distribution

  • 00817492012837 ()


  • Basic electric hospital bed
SCE+ Hosp -Scale
Hoffmann NOA Medical Industries, LLC
1055043GRY
In Commercial Distribution

  • 00817492012707 ()


  • Basic electric hospital bed
Odor Eliminator Spray - Scented
HOLLISTER INCORPORATED
7735
In Commercial Distribution

  • 20610075044782 ()
  • 10610075077356 ()
  • 30610075077350 ()
7735

  • Ostomy odour-absorbent/deodorizer
Odor Eliminator Spray - Scented
HOLLISTER INCORPORATED
7734
In Commercial Distribution

  • 30610075077343 ()
  • 10610075077349 ()
  • 40610075077340 ()
7734

  • Ostomy odour-absorbent/deodorizer
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
Wounded Warrior PPE Kit- Extra Large; Each Kit Includes Extra Large Nitrile Exam Glove (2), 2 oz Scented Hand Sanitizer, Large Alcohol Prep Pad (4), and 3 Ply Mask.
Bosma Enterprises
10-90702XL
Not in Commercial Distribution

  • 10818634024906 ()
  • 00818634024909 ()

  • Extra Large
10-90702XL

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
  • Skin cleaning wipe
  • Public face mask, single-use
Wounded Warrior PPE Kit-Large; Each Kit Includes Large Nitrile Exam Glove (2), 2 oz Scented Hand Sanitizer, Large Alcohol Prep Pad (4), and 3 Ply Mask.
Bosma Enterprises
10-90702LG
Not in Commercial Distribution

  • 10818634024890 ()
  • 00818634024893 ()

  • Large
10-90702LG

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
  • Skin cleaning wipe
  • Public face mask, single-use
Wounded Warrior PPE Kit-Medium; Each Kit Includes Medium Nitrile Exam Glove (2), 2 oz Scented Hand Sanitizer, Large Alcohol Prep Pad (4), and 3 Ply Mask.
Bosma Enterprises
10-90702MD
Not in Commercial Distribution

  • 10818634024883 ()
  • 00818634024886 ()

  • Medium
10-90702MD

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
  • Skin cleaning wipe
  • Public face mask, single-use
Wounded Warrior PPE Kit-Small; Each Kit Includes Small Nitrile Exam Glove (2), 2 oz Scented Hand Sanitizer, Large Alcohol Prep Pad (4), and 3 Ply Mask.
Bosma Enterprises
10-90702S
Not in Commercial Distribution

  • 10818634024876 ()
  • 00818634024879 ()

  • Small
10-90702S

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
  • Skin cleaning wipe
  • Public face mask, single-use
Wounded Warrior PPE Kit-XLarge; Each Kit Includes XLarge Nitrile Exam Glove (2), 2 oz Scented Hand Sanitizer, Large Alcohol Prep Pad (4), and 3 Ply Mask.
Bosma Enterprises
10-90701XL
Not in Commercial Distribution

  • 10818634024869 ()
  • 00818634024862 ()
10-90701XL

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
  • Skin cleaning wipe
  • Public face mask, single-use
Wounded Warrior PPE Kit-Large; Each Kit Includes Large Nitrile Exam Glove (2), 2 oz Scented Hand Sanitizer, Large Alcohol Prep Pad (4), and 3 Ply Mask.
Bosma Enterprises
10-90701LG
Not in Commercial Distribution

  • 10818634024852 ()
  • 00818634024855 ()
10-90701LG

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
  • Skin cleaning wipe
  • Public face mask, single-use
Wounded Warrior PPE Kit-Medium; Each Kit Includes Medium Nitrile Exam Glove (2), 2 oz Scented Hand Sanitizer, Large Alcohol Prep Pad (4), and 3 Ply Mask.
Bosma Enterprises
10-90701MD
Not in Commercial Distribution

  • 10818634024845 ()
  • 00818634024848 ()
10-90701MD

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
  • Skin cleaning wipe
  • Public face mask, single-use
Wounded Warrior PPE Kit-Small; Each Kit Includes Small Nitrile Exam Glove (2), 2 oz Scented Hand Sanitizer, Large Alcohol Prep Pad (4), and 3 Ply Mask.
Bosma Enterprises
10-90701S
Not in Commercial Distribution

  • 10818634024838 ()
  • 00818634024831 ()
10-90701S

  • Skin cleaning wipe
  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
  • Public face mask, 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
Argene CINAKit is intended for use as an aid in the diagnosis of Cytomegalovirus (CMV) infection by the qualitative detection of CMV pp65 antigen by indirect immunofluore scence
BIOMERIEUX SA
19-0028US
Not in Commercial Distribution

  • 03573026390273 ()


  • Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay
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