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Head Phones Slim is part of NordicNeuroLab’s Audio System.
The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient wearing a set of headphones. A communication console allows the operator to adjust the sounds from the PC and to speak directly to the patient through a built-in microphone.
The Head Phone Slim is designed specifically for use in the MR environment, and are compatible with MR system up to 3T.
Nordicneurolab AS
HPS 1.0
Not in Commercial Distribution
- 07090042053020 ()
- Auditory stimulator
Head Phones is part of NordicNeuroLab’s Audio System.
The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient wearing a set of headphones. A communication console allows the operator to adjust the sounds from the PC and to speak directly to the patient through a built-in microphone.
The Head Phone is designed specifically for use in the MR environment, and are compatible with MR system up to 3T.
Nordicneurolab AS
HP 1.3
In Commercial Distribution
- 07090042053013 ()
- Auditory stimulator
Fluorescence imaging system
FLUOPTICS
FBLXR
In Commercial Distribution
- B475FBLXR0 ()
- Intraoperative parathyroid detection system control unit
- Diagnostic-imaging multiformat camera
Fluorescence imaging system
FLUOPTICS
FBLX
In Commercial Distribution
- B475FBLX0 ()
- Diagnostic-imaging multiformat camera
- Intraoperative parathyroid detection system control unit
The HidraWear AX device is a garment device, which is intended for the retention of a dressing in the axillar area. The HidraMed AX is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn over a brassiere and is then applied to the axillar area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care.
Size: Extra Extra Large
HIDRAMED SOLUTIONS LIMITED
GAX001-05
In Commercial Distribution
- 05391535510092 ()
- Non-adhesive device retention bandage
The HidraWear AX device is a garment device, which is intended for the retention of a dressing in the axillar area. The HidraMed AX is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn over a brassiere and is then applied to the axillar area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care.
Size: Extra Large
HIDRAMED SOLUTIONS LIMITED
GAX001-04
In Commercial Distribution
- 05391535510030 ()
- Non-adhesive device retention bandage
The HidraWear AX device is a garment device, which is intended for the retention of a dressing in the axillar area. The HidraMed AX is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn over a brassiere and is then applied to the axillar area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care.
Size: Large
HIDRAMED SOLUTIONS LIMITED
GAX001-03
In Commercial Distribution
- 05391535510023 ()
- Non-adhesive device retention bandage
The HidraWear AX device is a garment device, which is intended for the retention of a dressing in the axillar area. The HidraMed AX is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn over a brassiere and is then applied to the axillar area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care.
Size: Medium
HIDRAMED SOLUTIONS LIMITED
GAX001-02
In Commercial Distribution
- 05391535510016 ()
- Non-adhesive device retention bandage
The HidraWear AX device is a garment device, which is intended for the retention of a dressing in the axillar area. The HidraMed AX is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn over a brassiere and is then applied to the axillar area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care.
Size: Small
HIDRAMED SOLUTIONS LIMITED
GAX001-01
In Commercial Distribution
- 05391535510009 ()
- Non-adhesive device retention bandage
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 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
Used with the Nevisense to perform lesion examinations on patients, using disposable electrodes attached to the probe.
Scibase AB
512-0003
In Commercial Distribution
- 07350094440088 ()
512-0003
- Neoplasm electrical impedance spectrometer
Platelet PGDprime Transfer Pipettes required to move the processed platelet sample to the Platelet PGDprime Test Device.
Verax Biomedical Incorporated
P01229
In Commercial Distribution
- 10850046056243 ()
- 10850046056083 ()
- Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical
The Vaccine Administration Kit, Facility, contains the necessary items to prepare up to 100 patients for inoculation.
Altitude Technologies Inc.
04656
In Commercial Distribution
- 00850018892919 ()
04656
- General surgical procedure kit, non-medicated, single-use
A qualitative test to detect the LH surge in urine to aid in the prediction of ovulation.
GERMAINE LABORATORIES, INC
75030
In Commercial Distribution
- 00695684750305 ()
- 00695684750301 ()
- Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Beurer Fertility Convenience Kit with Pearl App
Each kit contains:
15 FSH test strips,
15 LH test strips,
2 hCG test strips (pregnancy test),
Access (activation code) for the Pearl Fertility App.
BEURER NORTH AMERICA, L.P.
OT80
In Commercial Distribution
- 00850003500478 ()
- 10850003500475 ()
- 20850003500472 ()
792.97
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
- Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
- Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing
The AeroWrap Thigh™ system is intended to provide compression to the great saphenous vein on the thigh after closure to occlude the vein after surgery. The wrap consists of a inflatable portion that covers the inner thigh and additional material along with areas for securing the wrap to the thigh. The wrap also has loops for a belt to maintain the proper location. The placement of the wrap and sv bolster will help to aid in the closure of Various veins with Sclerotherapy including EVLT, RFMD, for compression of the great saphenous vein.
SUN SCIENTIFIC, INC.
TW6250-03
In Commercial Distribution
- 00856525007327 ()
TWMLR
- Compression/pressure tubular garment
The AeroWrap Thigh™ system is intended to provide compression to the great saphenous vein on the thigh after closure to occlude the vein after surgery. The wrap consists of a inflatable portion that covers the inner thigh and additional material along with areas for securing the wrap to the thigh. The wrap also has loops for a belt to maintain the proper location. The placement of the wrap and sv bolster will help to aid in the closure of Various veins with Sclerotherapy including EVLT, RFMD, for compression of the great saphenous vein.
SUN SCIENTIFIC, INC.
TW6150-03
In Commercial Distribution
- 00856525007211 ()
TWSR
- Compression/pressure tubular garment
The AeroWrap Thigh™ system is intended to provide compression to the great saphenous vein on the thigh after closure to occlude the vein after surgery. The wrap consists of a inflatable portion that covers the inner thigh and additional material along with areas for securing the wrap to the thigh. The wrap also has loops for a belt to maintain the proper location. The placement of the wrap and sv bolster will help to aid in the closure of Various veins with Sclerotherapy including EVLT, RFMD, for compression of the great saphenous vein.
SUN SCIENTIFIC, INC.
TW6150-01
In Commercial Distribution
- 00856525007150 ()
TWSL
- Compression/pressure tubular garment
The AeroWrap Thigh™ system is intended to provide compression to the great saphenous vein on the thigh after closure to occlude the vein after surgery. The wrap consists of a inflatable portion that covers the inner thigh and additional material along with areas for securing the wrap to the thigh. The wrap also has loops for a belt to maintain the proper location. The placement of the wrap and sv bolster will help to aid in the closure of Various veins with Sclerotherapy including EVLT, RFMD, for compression of the great saphenous vein.
SUN SCIENTIFIC, INC.
TW6250-01
In Commercial Distribution
- 00856525007099 ()
TWMLL
- Compression/pressure tubular garment
While vibrating at a high speed, the microtips of this device apply physical stimulation to the facial skin to facilitate active ingredients to penetrate in the skin.
EUNSUNG GLOBAL CORP.
ESK-2162HJ
In Commercial Distribution
- 08800060501668 ()
- Analgesic transcutaneous electrical nerve stimulation system
Healing Abutments are intended for placement onto the implant during stage II surgery. As the tissue heals, it conforms to the contours of the abutment. As the gingiva heals, the tissue adapts to the form of the healing abutment, creating permanent oral access to the implant and prepares the gingiva for the restorative phase.
STERNGOLD DENTAL LLC
901469
Not in Commercial Distribution
- 00841549108150 ()
- Dental implant suprastructure, permanent, preformed
Healing Abutments are intended for placement onto the implant during stage II surgery. As the tissue heals, it conforms to the contours of the abutment. As the gingiva heals, the tissue adapts to the form of the healing abutment, creating permanent oral access to the implant and prepares the gingiva for the restorative phase.
STERNGOLD DENTAL LLC
901468
Not in Commercial Distribution
- 00841549108143 ()
- Dental implant suprastructure, permanent, preformed
Healing Abutments are intended for placement onto the implant during stage II surgery. As the tissue heals, it conforms to the contours of the abutment. As the gingiva heals, the tissue adapts to the form of the healing abutment, creating permanent oral access to the implant and prepares the gingiva for the restorative phase.
STERNGOLD DENTAL LLC
901467
Not in Commercial Distribution
- 00841549108136 ()
- Dental implant suprastructure, permanent, preformed
Healing Abutments are intended for placement onto the implant during stage II surgery. As the tissue heals, it conforms to the contours of the abutment. As the gingiva heals, the tissue adapts to the form of the healing abutment, creating permanent oral access to the implant and prepares the gingiva for the restorative phase.
STERNGOLD DENTAL LLC
901466
Not in Commercial Distribution
- 00841549108129 ()
- Dental implant suprastructure, permanent, preformed
Healing Abutments are intended for placement onto the implant during stage II surgery. As the tissue heals, it conforms to the contours of the abutment. As the gingiva heals, the tissue adapts to the form of the healing abutment, creating permanent oral access to the implant and prepares the gingiva for the restorative phase.
STERNGOLD DENTAL LLC
901465
Not in Commercial Distribution
- 00841549108112 ()
- Dental implant suprastructure, permanent, preformed
Healing Abutments are intended for placement onto the implant during stage II surgery. As the tissue heals, it conforms to the contours of the abutment. As the gingiva heals, the tissue adapts to the form of the healing abutment, creating permanent oral access to the implant and prepares the gingiva for the restorative phase.
STERNGOLD DENTAL LLC
901464
Not in Commercial Distribution
- 00841549108105 ()
- Dental implant suprastructure, permanent, preformed
Healing Abutments are intended for placement onto the implant during stage II surgery. As the tissue heals, it conforms to the contours of the abutment. As the gingiva heals, the tissue adapts to the form of the healing abutment, creating permanent oral access to the implant and prepares the gingiva for the restorative phase.
STERNGOLD DENTAL LLC
901448
In Commercial Distribution
- 00841549107962 ()
- Dental implant suprastructure, permanent, preformed
Healing Abutments are intended for placement onto the implant during stage II surgery. As the tissue heals, it conforms to the contours of the abutment. As the gingiva heals, the tissue adapts to the form of the healing abutment, creating permanent oral access to the implant and prepares the gingiva for the restorative phase.
STERNGOLD DENTAL LLC
901097
Not in Commercial Distribution
- 00841549107047 ()
- Dental implant suprastructure, permanent, preformed
Healing Caps are intended for placement onto the implant during stage II surgery. As the tissue heals, it conforms to the contours of the abutment. As the gingiva heals, the tissue adapts to the form of the healing abutment, creating permanent oral access to the implant and prepares the gingiva for the restorative phase.
STERNGOLD DENTAL LLC
901096
Not in Commercial Distribution
- 00841549107030 ()
- Dental implant suprastructure, permanent, preformed