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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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Arthrodesis Nail System Fully Threaded Screw ø5.0 L.20mm
Ascension Orthopedics, Inc.
PAN-1010-1420
Not in Commercial Distribution

  • 10381780504481 ()

  • ø5.0 L.20mm
PAN-1010-1420

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Arthrodesis Nail System Fully Threaded Screw ø5.0 L18mm
Ascension Orthopedics, Inc.
PAN-1010-1418NS
In Commercial Distribution

  • 10381780504474 ()

  • ø5.0 L18mm
PAN-1010-1418NS

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Arthrodesis Nail System Fully Threaded Screw ø5.0 L18mm
Ascension Orthopedics, Inc.
PAN-1010-1418
Not in Commercial Distribution

  • 10381780504467 ()

  • ø5.0 L18mm
PAN-1010-1418

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Arthrodesis Nail System K-Wire, ø2.5mm x 150mm
Ascension Orthopedics, Inc.
PAN-1010-0210
In Commercial Distribution

  • 10381780505693 ()

  • ø2.5mm x 150mm
PAN-1010-0210

  • Orthopaedic bone wire
The PocketECG transmitter is a key component of PocketECG IV - Unified Arrhythmia Diagnostic System and is intended to: acquire, analyze, visualize, record or/and transmit the ECG and acceleration data. The PocketECG transmitter is attached to patient’s body with three electrodes. The device is battery powered from Lithium-ion battery (type: P4BA-AA-UNI or P4BA-AB-UNI) with rated voltage of 3.7 V and is designed for continuous use. PocketECG transmitter type: P4TR-AB-ADS is inteded for use in LTE cellular networks.
MEDICALGORITHMICS S A
P4TR-AB-ADS
In Commercial Distribution

  • 05903021560087 ()


  • Electrocardiography telemetric monitoring system
The PocketECG transmitter is a key component of PocketECG IV - Unified Arrhythmia Diagnostic System and is intended to: acquire, analyze, visualize, record or/and transmit the ECG and acceleration data. The PocketECG transmitter is attached to patient’s body with three electrodes. The device is battery powered from Lithium-ion battery (type: P4BA-AA-UNI or P4BA-AB-UNI) with rated voltage of 3.7 V and is designed for continuous use. PocketECG transmitter type: P4TR-AA-ADS is inteded for use in LTE cellular networks.
MEDICALGORITHMICS S A
P4TR-AA-ADS
In Commercial Distribution

  • 05903021560070 ()


  • Electrocardiography telemetric monitoring system
The PocketECG CRS transmitter type PECGT-IIIR is a key component of PocketECG CRS - Medicalgorithmics Unified Cardiac Rehabilitation System and is intended to: acquire, analyze, visualize, record or/and transmit the ECG and acceleration data. The PocketECG CRS transmitter is attached to patient’s body with three electrodes. The device is battery powered from Lithium-ion battery (type: PECGB-III) with rated voltage of 3.7 V and is designed for continuous use. The PocketECG CRS is inteded for use in GSM cellular networks.
MEDICALGORITHMICS S A
Type: PECGT-IIIR
In Commercial Distribution

  • 05903021560056 ()


  • Electrocardiography telemetric monitoring system
The PocketECG transmitter is a key component of the PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System and is intended to: acquire, analyze, visualize, record or/and transmit the ECG and acceleration data. The PocketECG transmitter is attached to patient’s body with three electrodes. The device is battery powered from Lithium-ion battery (type: PECGB-III) with rated voltage of 3.7 V and is designed for continuous use. PocketECG transmitter type: PECGT-IIIV is inteded for use in CDMA cellular networks.
MEDICALGORITHMICS S A
Type: PECGT-IIIV
In Commercial Distribution

  • 05903021560025 ()


  • Electrocardiography telemetric monitoring system
The PocketECG transmitter is a key component of PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System and is intended to: acquire, analyze, visualize, record or/and transmit the ECG and acceleration data. The PocketECG transmitter is attached to patient’s body with three electrodes. The device is battery powered from Lithium-ion battery (type: PECGB-III) with rated voltage of 3.7 V and is designed for continuous use. PocketECG transmitter type: PECGT-III is inteded for use in GSM cellular networks.
MEDICALGORITHMICS S A
Type: PECGT-III
In Commercial Distribution

  • 05903021560018 ()


  • Electrocardiography telemetric monitoring system
EmbaGYN Pelvic Floor Exerciser is a portable, battery operated electrical muscle stimulator. EmbaGYN is indicated for the rehabilitation and strengthening of weak pelvic floor muscles in the treatment of stress, urge, and mixed urinary incontinence. It is designed to be extremely easy to use, and is intended for daily use by the patient in their own home. The EmbaGYN is supplied with a Liberty vaginal electrode that may not be sterilised and is intended for single patient use.
TENSCARE LIMITED
itouch Sure
In Commercial Distribution

  • 05033435132171 ()
K-EMBAGYN

  • Perineal orifice incontinence-control electrical stimulation system
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