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The Vertigenius™ system is intended to assist in the delivery and tracking of a prescribed exercise regime for Vestibular and Balance Rehabilitation.
The Vertigenius™ system comprises a sensor that is worn behind the ear that detects head movement, a companion smart phone app and clinician
platform. Vestibular rehabilitation exercises are prescribed by clinicians for their patient using the Vertigenius™ application platform.
Vertigenius™ can be used with or without the head sensor. The companion app delivers the prescribed exercise regime, provides auditory and visual
cues, tracks symptoms and monitors adherence. The head sensor is worn whilst the patient is carrying out specific prescribed head movement
exercises for Vestibular and Balance Rehabilitation. It is used to provide real-time feedback to the patient so that they can see if they are carrying out
the prescribed exercises correctly. The sensor and connected app provide feedback via the clinician platform to the prescribing clinician on the quality
of exercise performance, changes in symptoms and adherence of the patient to the prescribed exercises, enabling the clinician to remotely monitor
progress.
DIGITAL REHABILITATION LIMITED
2.2.0
Not in Commercial Distribution
- 05391548420012 ()
VGCP01
- Biomechanical function analysis/rehabilitation software
The Vertigenius™ system is intended to assist in the delivery and tracking of a prescribed exercise regime for Vestibular and Balance Rehabilitation.
The Vertigenius™ system comprises a sensor that is worn behind the ear that detects head movement, a companion smart phone app and clinician
platform. Vestibular rehabilitation exercises are prescribed by clinicians for their patient using the Vertigenius™ application platform.
Vertigenius™ can be used with or without the head sensor. The companion app delivers the prescribed exercise regime, provides auditory and visual
cues, tracks symptoms and monitors adherence. The head sensor is worn whilst the patient is carrying out specific prescribed head movement
exercises for Vestibular and Balance Rehabilitation. It is used to provide real-time feedback to the patient so that they can see if they are carrying out
the prescribed exercises correctly. The sensor and connected app provide feedback via the clinician platform to the prescribing clinician on the quality
of exercise performance, changes in symptoms and adherence of the patient to the prescribed exercises, enabling the clinician to remotely monitor
progress.
DIGITAL REHABILITATION LIMITED
2
In Commercial Distribution
- 05391548420005 ()
VGAPP01
- Biomechanical function analysis/rehabilitation software
Titanium alloy cross elements are designed to provide additional support to the humeral head by entering the posts perpendicular to the axis of the cortical thread of the posts.
TOBY ORTHOPAEDICS
NA
In Commercial Distribution
- 00816101010196 ()
TO-20-CE-35
- Orthopaedic bone screw (non-sliding)
Titanium alloy cross elements are designed to provide additional support to the humeral head by entering the posts perpendicular to the axis of the cortical thread of the posts.
TOBY ORTHOPAEDICS
NA
In Commercial Distribution
- 00816101010189 ()
TO-20-CE-30
- Orthopaedic bone screw (non-sliding)
Titanium alloy cross elements are designed to provide additional support to the humeral head by entering the posts perpendicular to the axis of the cortical thread of the posts.
TOBY ORTHOPAEDICS
NA
In Commercial Distribution
- 00816101010172 ()
TO-20-CE-25
- Orthopaedic bone screw (non-sliding)
Used with the slide labeller to print stick on labels to attach to slides. The slides are used on the BOND instrument.
LEICA BIOSYSTEMS MELBOURNE PTY LTD
BOND Printer Ribbon & Labels Cxi (6 Pack)
In Commercial Distribution
- 09349458002633 ()
S21.4610
- Microscope slide stainer IVD
Used with the slide labeller to print stick on labels to attach to slides. The slides are used on the BOND instrument.
LEICA BIOSYSTEMS MELBOURNE PTY LTD
Printer Ribbon & Labels for Cognitive Cxi (6 Pack)
In Commercial Distribution
- 09349458005641 ()
S21.4610
- Microscope slide stainer IVD
Used with the slide labeller to print stick on labels to attach to slides. The slides are used on the BOND instrument.
LEICA BIOSYSTEMS MELBOURNE PTY LTD
Printer Ribbon & Labels for Cognitive Cxi (6 Pack)
In Commercial Distribution
- 09349458005634 ()
S21.4604
- Microscope slide stainer IVD
Used with the slide labeller to print stick on labels to attach to slides. The slides are used on the BOND instrument.
LEICA BIOSYSTEMS MELBOURNE PTY LTD
BOND Printer Ribbon & Labels Cxi (1 Pack)
In Commercial Distribution
- 09349458005283 ()
S21.4604
- Microscope slide stainer IVD
Used with the slide labeller to print stick on labels to attach to slides. The slides are used on the BOND instrument.
LEICA BIOSYSTEMS MELBOURNE PTY LTD
BOND Slide Labels and Printing Ribbon
In Commercial Distribution
- 09349458005269 ()
S21.4564
- Microscope slide stainer IVD
Exerciser to increase flexion and the extension range of motion of the joints of the second to the fifth fingers of the hand
LANTZ MEDICAL, INC.
Vector 1
In Commercial Distribution
- B770VEC0 ()
Vector 1
- Hand/wrist continuous passive motion exerciser
Suji device for BFR training. Suji comprises of a BLE enable pump, compression bands and a mobile app. The compression bands are worn at the top of the limb to restrict blood flow during exercise.
SECONDPERSPECTIVE LTD.
V2MDR-01
In Commercial Distribution
- 05070000320403 ()
- Tourniquet cuff, reusable
Cable to connect disposable hand sensor to the ToFscan
IDMED
TOF-CS1
In Commercial Distribution
- 03665023000474 ()
TOF-CS1
- Neuromuscular transmission lead set
Suction tubes for Sinus are used to remove excess amount of foreign body material from sinus.
EON MEDITECH PRIVATE LIMITED
EI1840150
In Commercial Distribution
- 08906039318265 ()
- 08906039319118 ()
- 08904461001786 ()
- Outer Diameter: 4.0 Millimeter
- Length: 150.0 Millimeter
- Angle: 30 degree
- ENT suction dissector
Suction tubes for Sinus are used to remove excess amount of foreign body material from sinus.
EON MEDITECH PRIVATE LIMITED
EI1830150
In Commercial Distribution
- 08906039318340 ()
- 08906039318111 ()
- 08904461001779 ()
- Outer Diameter: 3.0 Millimeter
- Length: 150.0 Millimeter
- Angle: 30 degree
- ENT suction dissector
Suction tubes for Sinus are used to remove excess amount of foreign body material from sinus.
EON MEDITECH PRIVATE LIMITED
EI1825150
In Commercial Distribution
- 08906039318364 ()
- 08906039317114 ()
- 08904461001809 ()
- Outer Diameter: 2.5 Millimeter
- Length: 150.0 Millimeter
- Angle: 30 degree
- ENT suction dissector
Suction tubes for Throat are used to remove excess amount of foreign body material from throat.
EON MEDITECH PRIVATE LIMITED
EI1620250
In Commercial Distribution
- 08906039318395 ()
- 08906039315110 ()
- Outer Diameter: 2.0 Millimeter
- Length: 250.0 Millimeter
- Angle: 30 degree
- ENT suction dissector
Suction tubes for Throat are used to remove excess amount of foreign body material from throat.
EON MEDITECH PRIVATE LIMITED
EI1630250
In Commercial Distribution
- 08904461013109 ()
- 08904461011198 ()
- 08904461013260 ()
- Outer Diameter: 3.0 Millimeter
- Length: 250.0 Millimeter
- Angle: 30 degree
- ENT suction dissector
Suction tubes for Sinus are used to remove excess amount of foreign body material from sinus.
EON MEDITECH PRIVATE LIMITED
EI1840100
In Commercial Distribution
- 08904461006880 ()
- 08904461006842 ()
- Length: 100.0 Millimeter
- Angle: 30 degree
- Outer Diameter: 4.0 Millimeter
- ENT suction dissector
Suction tubes for Sinus are used to remove excess amount of foreign body material from sinus.
EON MEDITECH PRIVATE LIMITED
EI1830100
In Commercial Distribution
- 08904461006873 ()
- 08904461006835 ()
- Outer Diameter: 3.0 Millimeter
- Length: 100.0 Millimeter
- Angle: 30 degree
- ENT suction dissector
Suction tubes for Sinus are used to remove excess amount of foreign body material from sinus.
EON MEDITECH PRIVATE LIMITED
EI1825100
In Commercial Distribution
- 08904428747443 ()
- 08904428724062 ()
- Outer Diameter: 2.5 Millimeter
- Length: 100.0 Millimeter
- Angle: 30 degree
- ENT suction dissector
G5 Mobile Android App Stand Alone Software
Dexcom, Inc.
SW10940
In Commercial Distribution
- 00386270000293 ()
- Percutaneous interstitial-fluid glucose monitoring system, electrochemical
G5 Mobile IOS App Stand Alone Software
Dexcom, Inc.
SW10611
In Commercial Distribution
- 00386270000002 ()
- Percutaneous interstitial-fluid glucose monitoring system, electrochemical
DreamMapper App iOS, Asia-Pacific Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution
- 00606959054288 ()
1127959
- Self-care monitoring/reporting software
DreamMapper App iOS, EMEA Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution
- 00606959054271 ()
1128264
- Self-care monitoring/reporting software
SOFTWARE 9734472 SONONAV CAL APP FOR SC
MEDTRONIC NAVIGATION, INC.
9734472
In Commercial Distribution
- 00643169183407 ()
- Multi-purpose stereotactic surgery system
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
FLEXICARE MEDICAL LIMITED
038-94-620U
In Commercial Distribution
- 05055788777694 ()
- Laryngeal mask airway, single-use
Rabbit Polyclonal Anti-Human Amyloid Precursor Protein (APP)
RICHARD-ALLAN SCIENTIFIC COMPANY
RB-9023-P
In Commercial Distribution
- 00673693398558 ()
- Total Volume: 1 Milliliter
- Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Rabbit Polyclonal Anti-Human Amyloid Precursor Protein (APP)
RICHARD-ALLAN SCIENTIFIC COMPANY
RB-9023-R7
In Commercial Distribution
- 00673693398602 ()
- Total Volume: 7 Milliliter
- Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Rabbit Polyclonal Anti-Human Amyloid Precursor Protein (APP)
RICHARD-ALLAN SCIENTIFIC COMPANY
RB-9023-P1
In Commercial Distribution
- 00673693398572 ()
- Total Volume: 0.5 Milliliter
- Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Rabbit Polyclonal Anti-Human Amyloid Precursor Protein (APP)
RICHARD-ALLAN SCIENTIFIC COMPANY
RB-9023-P0
In Commercial Distribution
- 00673693398565 ()
- Total Volume: 0.1 Milliliter
- Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
OB V2 RING KIT TI LG-No App
OSSUR AMERICAS, INC.
515500V2
Not in Commercial Distribution
- 05690977308695 ()
515500V2
- Cervical spine immobilization head ring
OB V2 RING KIT TI STD-No App
OSSUR AMERICAS, INC.
515400V2
Not in Commercial Distribution
- 05690977308688 ()
515400V2
- Cervical spine immobilization head ring
OB V2 RING KIT TI SM-No App
OSSUR AMERICAS, INC.
515300V2
Not in Commercial Distribution
- 05690977308671 ()
515300V2
- Cervical spine immobilization head ring
A mobile app for HANSATON hearing instruments
Sonova AG
088-5018
In Commercial Distribution
- 07613389610932 ()
- Audiometric/hearing device software
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Bio Compression Systems, Inc
G8-3035-SH-M-L
In Commercial Distribution
- 00812311029119 ()
- Multi-chamber venous compression system garment, reusable
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Bio Compression Systems, Inc
G8-3035-SH-M-L-BT
In Commercial Distribution
- 00812311020062 ()
- Multi-chamber venous compression system garment, reusable
APP PAD W/O HEAD & FOOT FLAPS
COMPASS HEALTH BRANDS CORP.
1002
In Commercial Distribution
- 30815067040170 ()
- 00815067040179 ()
- Alternating-pressure bed mattress overlay, reusable
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
MAR COR PURIFICATION, INC.
102M16B2E
In Commercial Distribution
- 00817492021969 ()
- Width: 38 Inch
- Depth: 29 Inch
- Height: 80.5 Inch
- Weight: 783 Pound
- Reverse-osmosis water purification system
App Control for ACRL-9100 Device v.1
COMPASS HEALTH BRANDS CORP.
ACRL-9100APP
- Physical therapy transcutaneous neuromuscular electrical stimulation system