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Transmitter which is part of a multi-patient physiologic monitoring system
LIFE SENSING INSTRUMENTS, INC.
TM8D Transmitter
In Commercial Distribution
- 00864037000309 ()
- Multiple-patient intensive/general healthcare physiologic monitoring system
DenSureFit is an over-the-counter soft reline kit. It consists of 2 applicators of vinyl polysiloxane, 1 vial primer, 2 stick applicators and 1 IFU.
The kit is intended to reline one denture plate. It is intended to provide temporary relief from ill-fitting dentures until a dentist can be seen.
OTC DENTAL CORPORATION
DSF212.00
In Commercial Distribution
- 00863995000109 ()
- Denture reliner, soft, home-use
No Description
Altitude Technologies Inc.
5007
In Commercial Distribution
- 00863970000476 ()
- Nasogastric/orogastric tube
The VasoStat Hemostasis Device is used to augment hemostasis through a ratcheting pressure
mechanism.
Forge Medical, Inc.
10348-325-04
In Commercial Distribution
- 00863879000201 ()
- 10863879000208 ()
- 20863879000205 ()
- 30863879000202 ()
- 40863879000209 ()
- 50863879000206 ()
- Radial artery compression device
No Description
ASURAGEN, INC.
84001
In Commercial Distribution
- 00863840000285 ()
84001
- General specimen container IVD, additive/medium
NovoGro Putty is intended to be hydrated with ultra-pure water and gently packed into bony voids or gaps of the skeletal system.
OSTEONOVUS, INC.
NGC10X
In Commercial Distribution
- 00863787000478 ()
- 10 cc
- Bone matrix implant, synthetic, non-antimicrobial
NovoGro Putty is intended to be hydrated with ultra-pure water and gently packed into bony voids or gaps of the skeletal system.
OSTEONOVUS, INC.
NGC05X
In Commercial Distribution
- 00863787000461 ()
- 5 cc
- Bone matrix implant, synthetic, non-antimicrobial
NovoGro Putty is intended to be hydrated with ultra-pure water and gently packed into bony voids or gaps of the skeletal system.
OSTEONOVUS, INC.
NGC025X
In Commercial Distribution
- 00863787000454 ()
- 2.5 cc
- Bone matrix implant, synthetic, non-antimicrobial
NovoGro Putty is intended to be hydrated with ultra-pure water and gently packed into bony voids or gaps of the skeletal system.
OSTEONOVUS, INC.
NGC15
In Commercial Distribution
- 00863787000430 ()
- Bone matrix implant, synthetic, non-antimicrobial
NovoGro Putty is intended to be hydrated with ultra-pure water and gently packed into bony voids or gaps of the skeletal system.
OSTEONOVUS, INC.
NGC10
In Commercial Distribution
- 00863787000423 ()
- 10 cc
- Bone matrix implant, synthetic, non-antimicrobial
NovoGro Putty is intended to be hydrated with ultra-pure water and gently packed into bony voids or gaps of the skeletal system.
OSTEONOVUS, INC.
NGC05
In Commercial Distribution
- 00863787000416 ()
- 5 cc
- Bone matrix implant, synthetic, non-antimicrobial
NovoGro Putty is intended to be hydrated with ultra-pure water and gently packed into bony voids or gaps of the skeletal system.
OSTEONOVUS, INC.
NGC025
In Commercial Distribution
- 00863787000409 ()
- 2.5 cc
- Bone matrix implant, synthetic, non-antimicrobial
Electronic Pulse Stimulator set
1BYONEPRODUCTS INC.
PL-029K8(725EU-0001)
In Commercial Distribution
- 10863696000375 ()
- 00863696000378 ()
- 00863696000361 ()
- Analgesic transcutaneous electrical nerve stimulation system
Infrared Thermometer
1BYONEPRODUCTS INC.
JPD-FR401
In Commercial Distribution
- 10863696000351 ()
- 00863696000354 ()
- 00863696000347 ()
- Infrared patient thermometer, skin
Pulse Oximeter
1BYONEPRODUCTS INC.
JPD-500D
In Commercial Distribution
- 10863696000337 ()
- 00863696000330 ()
- 00863696000323 ()
- Pulse oximeter
Arm blood pressure monitor
1BYONEPRODUCTS INC.
TMB-1585
In Commercial Distribution
- 00863696000309 ()
- 00863696000316 ()
- 10863696000306 ()
- Telemetric sphygmomanometer
imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a central system manager component, a diagnostic workstation component, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the hem from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. imorgon Ultrasound PACS Solutions is also a teleradiology system used to receive DICOM images, scheduling information, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. imorgon Ultrasound PACS Solutions is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report
information.
IMORGON MEDICAL LLC
Imorgon Report Accelerator 1.4
In Commercial Distribution
- 00863670000349 ()
- Radiological PACS software
imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a central system manager component, a diagnostic workstation component, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the hem from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. imorgon Ultrasound PACS Solutions is also a teleradiology system used to receive DICOM images, scheduling information, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. imorgon Ultrasound PACS Solutions is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report
information.
IMORGON MEDICAL LLC
Imorgon iSite integrator 14.1
In Commercial Distribution
- 00863670000332 ()
- Radiological PACS software
imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a central system manager component, a diagnostic workstation component, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the hem from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. imorgon Ultrasound PACS Solutions is also a teleradiology system used to receive DICOM images, scheduling information, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. imorgon Ultrasound PACS Solutions is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report
information.
IMORGON MEDICAL LLC
Imorgon Server 2.2
In Commercial Distribution
- 00863670000325 ()
- Radiological PACS software
imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a central system manager component, a diagnostic
workstation component, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the hem from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. imorgon Ultrasound PACS Solutions is also a teleradiology system used to receive DICOM images, scheduling information, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. imorgon Ultrasound PACS Solutions is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report
information.
IMORGON MEDICAL LLC
Imorgon LaunchPad 2.5
In Commercial Distribution
- 00863670000318 ()
- Radiological PACS software
imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a central system manager component, a diagnostic workstation component, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the hem from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. imorgon Ultrasound PACS Solutions is also a teleradiology system used to receive DICOM images, scheduling information, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. imorgon Ultrasound PACS Solutions is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report
information.
IMORGON MEDICAL LLC
Imorgon View/Workstation 2.7
In Commercial Distribution
- 00863670000301 ()
- Radiological PACS software
Suction / Irrigation Set with Single Spike
SECQURE SURGICAL, CORP.
CQ3851ULT
In Commercial Distribution
- 00863634000491 ()
- Surgical irrigation/aspiration tubing set
Suction / Irrigation Set with Dual Spike
SECQURE SURGICAL, CORP.
CQ3850ULT
In Commercial Distribution
- 00863634000484 ()
- Surgical irrigation/aspiration tubing set
Large Platelet Agitator to continuously keep bags of Platelets moving. To be used alone or in conjunction with the Boekel Large Platelet Incubator 301550
BOEKEL INDUSTRIES, INC.
301300
In Commercial Distribution
- 00863626000225 ()
- Platelet agitator
Device used to agitate platelets. May be used alone if temperature can be maintained to 22 degrees C +/- 2 degrees. may be used in conjunction with the Boekel Small Platelet Incubator.
BOEKEL INDUSTRIES, INC.
301200
In Commercial Distribution
- 00863626000218 ()
301200
- Platelet agitator
XL Drill Sleeve – 4.0 mm
Si-Bone Inc.
400035
In Commercial Distribution
- 00863604000094 ()
- Sacroiliac joint transarticular fixation/arthrodesis implantation kit
XL Drill Sleeve – 7.0 mm
Si-Bone Inc.
400034
In Commercial Distribution
- 00863604000087 ()
- Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Drill Sleeve – 4.0 mm
Si-Bone Inc.
400024
In Commercial Distribution
- 00863604000070 ()
- Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Drill Sleeve – 7.0 mm
Si-Bone Inc.
400023
In Commercial Distribution
- 00863604000063 ()
- Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Guide Pin Extension Cap - 80mm
Si-Bone Inc.
501672
In Commercial Distribution
- 00863604000056 ()
- Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Neuromonitoring Kit
Si-Bone Inc.
400170
In Commercial Distribution
- 00863604000049 ()
- Nerve-locating system probe, single-use
No Description
Si-Bone Inc.
107590-90
In Commercial Distribution
- 00863604000032 ()
- Outer Diameter: 10.75 Millimeter
- Length: 90 Millimeter
- Sacroiliac joint transarticular fixation/arthrodesis implant, coated
No Description
Si-Bone Inc.
107585-90
In Commercial Distribution
- 00863604000025 ()
- Length: 85 Millimeter
- Outer Diameter: 10.75 Millimeter
- Sacroiliac joint transarticular fixation/arthrodesis implant, coated
No Description
Si-Bone Inc.
107580-90
In Commercial Distribution
- 00863604000018 ()
- Outer Diameter: 10.75 Millimeter
- Length: 80 Millimeter
- Sacroiliac joint transarticular fixation/arthrodesis implant, coated
No Description
Si-Bone Inc.
107575-90
In Commercial Distribution
- 00863604000001 ()
- Length: 75 Millimeter
- Outer Diameter: 10.75 Millimeter
- Sacroiliac joint transarticular fixation/arthrodesis implant, coated
No Description
OSTEOMEDIX, INC.
BDC-Cervical
In Commercial Distribution
- 00863602000300 ()
- Orthopaedic surgery tissue debris collector, single-use
The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a solution of up to 1.0% cobalt chloride and up to 2.0% N-Acetyl cysteine, in a ratio of 1:2. Zirconium oxide is sealed within the device. The length of the polymer capsule is between 5.5 mm and 10.0 mm, and the diameter is 1.0 mm. It is loaded in an implant needle and sterilized with Ethylene Oxide.
C4 IMAGING, LLC
F-01-03-0111
In Commercial Distribution
- 00863593000259 ()
- Radiological image marker, implantable
The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a solution of up to 1.0% cobalt chloride and up to 2.0% N-Acetyl cysteine, in a ratio of 1:2. Zirconium oxide is sealed within the device. The length of the polymer capsule is between 5.5 mm and 10.0 mm, and the diameter is between 0.9 mm and 1.2 mm.
C4 IMAGING, LLC
F-01-03-0011
In Commercial Distribution
- 00863593000242 ()
- Radiological image marker, implantable
The SIRIUS MRI Marker NS is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy sources containing one of the following isotopes: Iodine 125 (125I), Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy.
C4 IMAGING, LLC
F-01-01-0011
In Commercial Distribution
- 00863593000228 ()
- Brachytherapy source spacer
The SIRIUS MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier
sleeves and radionuclide brachytherapy sources containing one of the following isotopes: Iodine 125 (125I), Palladium 103
(103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed
prostatic malignancy.
C4 IMAGING, LLC
F-01-01-0001
In Commercial Distribution
- 00863593000211 ()
F-01-01-0001
- Brachytherapy source spacer
The SIRIUS MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy sources containing one of the following isotopes: Iodine 125 (125I), Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy.
C4 IMAGING, LLC
C-01-99-0014
Not in Commercial Distribution
- 00863593000204 ()
F-01-01-0001
- Brachytherapy source spacer
MEDITECH's Blood Bank application tightly integrates donor, unit, and patient history information with data in the health care information system (HCIS). The application flags abnormal test results, reports test and transfusion results, minimizes product waste, utilizes expert rules when recording, and performs error checks. It also generates turnaround time and workload statistics, compiles statistical reports, and automatically captures charges. Authorized users have the ability to view blood bank results from within the network or remotely. All of these features ensure patient safety and reduce turnaround times.
MEDICAL INFORMATION TECHNOLOGY, INC.
Client Server
In Commercial Distribution
- 00863529000117 ()
- Blood bank information system application software
MEDITECH's Blood Bank application tightly integrates donor, unit, and patient history information with data in the health care information system (HCIS). The application flags abnormal test results, reports test and transfusion results, minimizes product waste, utilizes expert rules when recording, and performs error checks. It also generates turnaround time and workload statistics, compiles statistical reports, and automatically captures charges. Authorized users have the ability to view blood bank results from within the network or remotely. All of these features ensure patient safety and reduce turnaround times.
MEDICAL INFORMATION TECHNOLOGY, INC.
Magic
In Commercial Distribution
- 00863529000100 ()
- Blood bank information system application software
No Description
Giles Scientific, Inc.
V3
In Commercial Distribution
- 00863504000217 ()
BV3
- Antimicrobial susceptibility/resistance testing interpretive software IVD
- Colony counter IVD, automated/semi-automated
The Compact is intended for breaking apart urinary tract stones, e.g., renal calyceal, renal pelvic, and ureteral stones.
The purpose of the Shock Wave Generator is to convert the electric energy stored in a capacitor into mechanical energy. By generating high-energy sparks under water, shock waves are produced. The reflectors then focus these waves to converge at the common therapeutic focal point (F2).
DIREX SYSTEMS CORP.
COMPACT
In Commercial Distribution
- 00863499000346 ()
- Spark-gap lithotripsy system
The Duet is indicated for use in the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones).
The Duet is a transportable Extracorporeal Shock Wave Lithotripsy device, which consists of Shock Wave Generator (SWAG), a Motorized Floating Treatment Table (MFT), and Computer Console. The Duet does not provide imaging or monitoring functions, but contain the necessary interfaces for fluoroscopy and ECG R Wave Synchronization. The Duet is small and Transportable and can be used in any room equipped with the proper anesthesia devices.
Special electrodes placed within two reflectors generate high-energy sparks, which can be controlled within defined limits. The shock waves generated by the sparks are focused through water and through the body to converge on the calculus. The shock waves must be generated and transmitted through liquid to assure that sufficient energy is delivered to the stone. A series of the focused shock waves is used for the stone disintegration.
DIREX SYSTEMS CORP.
COMPACT DUET
In Commercial Distribution
- 00863499000339 ()
- Spark-gap lithotripsy system
3Dscope is intended for acquisition, processing and display of fluoroscopy images.
It can be also used together with an extra-corporeal shockwave lithotripsy.
3Dscope enables:
• Visualization of various objects on fluoroscopy images (for example, kidney stones).
• Generation and storage of patient records.
• Comparing images obtained at different times.
• Generation and management of patient data files and fluoroscopy images.
The device is composed of the following units:
• Workstation Console, which contains the application software for the system indicators and image display of the following:
System status
Fluoroscopy images
• Gantry unit, which contains he HF X-Ray generator, image intensifier and digital camera. It performs the following:
Generator control
Image initial processing
Data transfer to the Workstation console.
DIREX SYSTEMS CORP.
3DSCOPE
In Commercial Distribution
- 00863499000322 ()
- Fluoroscopic x-ray system video image recording unit
INTEGRA is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment. The device consists of the following:
• UCON
• Integrated unit, includes the following:
Shock Wave Generator (SWAG)
Fluoroscopy device (X-Ray Module)
Patient Table
The SWAG includes a high voltage generator module, a Reflector module, and a water module, and is located under the patient table.
The Reflector is mechanically coupled to an X-Ray Tube Monoblock. The Reflector/ Monoblock assembly is attached via a U-arm to an Image Intensifier and a digital camera Module, for real time stone imaging.
The U-Arm assembly is motorized, such that all three modules (Reflector, Monoblock, and Image Intensifier) move simultaneously as one piece and can be displaced electrically in all three axes, thus enabling the stone to be lined up in the therapeutic focal point.
The patient and table do not move. The patient lies still on the table and only the
U-Arm Assembly moves until the stone is localized.
The UCON enables control over all operational aspects of the integrated unit via a software application.
The operator chooses the various parameters to control the treatment including the number of shocks, intensity, frequency, etc.
INTEGRA contains the necessary interfaces for ECG synchronization and ultrasonic imaging devices. INTEGRA can be used in any room equipped with the proper anesthesia equipment.
DIREX SYSTEMS CORP.
INTEGRA
In Commercial Distribution
- 00863499000315 ()
- Electromechanical lithotripsy system, extracorporeal
Duet Magna is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and the upper ureter.
The device incorporates two electromagnetic shockwaves transducers at complementary angles to the horizon. The transducers can be operated separately (Top/Bottom) or alternate.
A series of focused shockwaves produced by electromagnetic transducers are coupled to a patient flank and are made to converge on urinary stones and disintegrate them. The patient is placed on a treatment table and x-ray and/or ultrasonic imaging device to localize the stone.
The operator controls treatment parameters including shockwave intensity, pulse rate, the number of shocks and ECG Synchronization.
DIREX SYSTEMS CORP.
MAGNA
In Commercial Distribution
- 00863499000308 ()
10-MGNA-000
- Electromechanical lithotripsy system, extracorporeal
LifeSign QuikScreen 11:
Amphetamine (AMP) 1000 ng/ml
Phencyclidine (PCP) 25 ng/ml
Methamphetamine (MET) 1000 ng/ml
Opiate (OPI) 2000 ng/ml
Barbiturates (BAR) 300 ng/ml
Benzodiazepine (BZD) 300 ng/ml
Marijuana (THC) 50 ng/ml
Methadone (MAD) 300 ng/ml
Oxycodone (OXY) 100 ng/ml
Tricyclic Antidepressants (TCA) 1000 ng/ml
Cocaine (COC) 300ng/ml
Lifesign L.L.C.
60B02
Not in Commercial Distribution
- 20863480002100 ()
- 10863480002103 ()
- 00863480002106 ()
- Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical