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FEops HEARTguide Simulation Application
FEops
3.0.0
Not in Commercial Distribution
- 05430002070056 ()
05430002070056
- Radiology DICOM image processing application software
FEops HEARTguide™ is indicated for patient-specific simulation of transcatheter left atrial appendage occlusion (LAAO) device implantation during procedural planning.
The software performs computer simulation to predict implant frame deformation to support the evaluation for LAAO device size and placement.
FEops HEARTguide™ is intended to be used by qualified clinicians in conjunction with the simulated device instructions for use, the patient’s clinical history, symptoms, and other preprocedural evaluations, as well as the clinician’s professional judgment.
FEops HEARTguide™ is not intended to replace the simulated device instructions for use for final LAAO device selection and placement.
FEops HEARTguide™ is prescription use only.
FEops
1.4.1
Not in Commercial Distribution
- 05430002070032 ()
- Radiology DICOM image processing application software
Sunrise sensor 2 (single night)
Sunrise
2
In Commercial Distribution
- 05430001896091 ()
A600
- Home-use sleep apnoea recording system
Sunrise sensor 2 (multi-nights)
Sunrise
2
In Commercial Distribution
- 05430001896084 ()
A500
- Home-use sleep apnoea recording system
Sunrise sensor
Sunrise
1
In Commercial Distribution
- 05430001896060 ()
- Home-use sleep apnoea recording system
Sunrise software
Sunrise
1
In Commercial Distribution
- 05430001896015 ()
- Sleep disorder interpretive software, professional-only
No Description
Ectosense
Mini
In Commercial Distribution
- 05430001742039 ()
- 05430001742060 ()
- Home-use sleep apnoea recording system
NightOwl sensor kit.
Ectosense
01.00
In Commercial Distribution
- 05430001742022 ()
- Home-use sleep apnoea recording system
W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw.
W-Bone is supplied as a mix of cancellous and cortical particles in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.
Wishbone
WHA200
In Commercial Distribution
- 05430001477115 ()
- Weight: 2.0 Gram
- Dental bone matrix implant, animal-derived
W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw.
W-Bone is supplied as a mix of cancellous and cortical particles in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.
Wishbone
WHA100
In Commercial Distribution
- 05430001477108 ()
- Weight: 1.0 Gram
- Dental bone matrix implant, animal-derived
W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw.
W-Bone is supplied as a mix of cancellous and cortical particles in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.
Wishbone
WHA050
In Commercial Distribution
- 05430001477092 ()
- Weight: 0.50 Gram
- Dental bone matrix implant, animal-derived
W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw.
W-Bone is supplied as a mix of cancellous and cortical particles in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.
Wishbone
WHA025
In Commercial Distribution
- 05430001477085 ()
- Weight: 0.25 Gram
- Dental bone matrix implant, animal-derived
Persyst ESI powered by Epilog provides Electrical Source Imaging as a service to a clinical user. The clinical user does not interact directly with the device. In the Persyst ESI powered by Epilog service, the device is used by Epilog operators to generate a report.
Persyst ESI powered by Epilog is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.
Clouds of Care
v2
- Bioelectrical signal analysis software
PreOp is active medical device software (MSDW) intended for use by a trained Epilog EEG technologist / Operator in combination with Persyst EEG Review and Analysis Software on both adult and pediatric subjects at least 3 years of age for 3D visualization of the human brain function recorded with EEG and using a patient-specific MR image.
Clouds of Care
v2
- Bioelectrical signal analysis software
CENTRAL LINE DRESSING TRAY
MEDLINE INDUSTRIES, INC.
DYNDC2287A
In Commercial Distribution
- 10889942206261 ()
DYNDC2287A
- General surgical procedure kit, non-medicated, reusable
C-SECTION PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0129799Q
In Commercial Distribution
- 10889942206230 ()
- 40889942206231 ()
DYNJ0129799Q
- General surgical procedure kit, non-medicated, reusable
OPEN HEART PACK
MEDLINE INDUSTRIES, INC.
DYNJ45630B
In Commercial Distribution
- 10889942206209 ()
DYNJ45630B
- General surgical procedure kit, non-medicated, single-use
C-SECTION PACK
MEDLINE INDUSTRIES, INC.
DYNJ45636B
In Commercial Distribution
- 10889942206193 ()
DYNJ45636B
- General surgical procedure kit, non-medicated, reusable
VAGINAL DELIVERY PACK
MEDLINE INDUSTRIES, INC.
DYNJ45635C
In Commercial Distribution
- 10889942206186 ()
DYNJ45635C
- General surgical procedure kit, non-medicated, reusable
TOTAL HIP
MEDLINE INDUSTRIES, INC.
DYNJ45657A
In Commercial Distribution
- 10889942206162 ()
- 40889942206163 ()
DYNJ45657A
- General surgical procedure kit, non-medicated, single-use