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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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Vivaer ARC Stylus - 08886479300146

The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The Vivaer ARC Stylus consists of a handle, shaft and treatment tip. An array of bipolar electrodes is positioned on a non-conductive tip which is attached to a handle via a non-conductive shaft. A temperature sensor is located on the tip to monitor tissue temperature. The Stylus is intended to attach to a temperature-controlled radiofrequency generator (Aerin Console) via a flexible cable.
Aerin Medical Inc.
FG257
In Commercial Distribution

  • 08886479300146 ()
CAT410

  • Electrosurgical system

NA - 04546540903877

T4 Eight Station Battery Charger 230V~ 50-60Hz 0.9A
STRYKER CORPORATION
0400655001
In Commercial Distribution

  • 04546540903877 ()
0400655001

  • Surgical helmet system

NA - 04546540903839

T4 Eight Station Battery Charger 120V~ 50-60Hz 1.7A
STRYKER CORPORATION
0400655000
In Commercial Distribution

  • 04546540903839 ()
0400655000

  • Surgical helmet system

NA - 04546540867360

CBCII Double Trocar Kit with Drain
STRYKER CORPORATION
0225028626
Not in Commercial Distribution

  • 34546540867361 ()
  • 04546540867360 ()

  • Diameter: 4.8 Millimeter
0225-028-626

  • Closed-wound drain, non-bioabsorbable

NA - 04546540867346

CBCII Double Trocar Kit with Drain
STRYKER CORPORATION
0225028616
Not in Commercial Distribution

  • 34546540867347 ()
  • 04546540867346 ()

  • Diameter: 6.4 Millimeter
0225-028-616

  • Whole-blood-recovery autotransfusion system, manual

NA - 04546540867322

CBCII Double Trocar Kit with Drain
STRYKER CORPORATION
0225028614
Not in Commercial Distribution

  • 34546540867323 ()
  • 04546540867322 ()

  • Diameter: 3.2 Millimeter
0225-028-614

  • Whole-blood-recovery autotransfusion system, manual

NA - 04546540867292

CBCII Blood Conservation Kit with Round PVC Drain and Curved Trocar
STRYKER CORPORATION
0225028526
Not in Commercial Distribution

  • 34546540867293 ()
  • 04546540867292 ()

  • Diameter: 4.8 Millimeter
0225-028-526

  • Whole-blood-recovery autotransfusion system, manual

NA - 04546540867278

CBCII Blood Conservation Kit with Round PVC Drain and Curved Trocar
STRYKER CORPORATION
0225028516
Not in Commercial Distribution

  • 34546540867279 ()
  • 04546540867278 ()

  • Diameter: 6.4 Millimeter
0225-028-516

  • Whole-blood-recovery autotransfusion system, manual

NA - 04546540867247

CBCII Blood Conservation Kit with Round PVC Drain and Curved Trocar
STRYKER CORPORATION
0225028514
Not in Commercial Distribution

  • 34546540867248 ()
  • 04546540867247 ()

  • Diameter: 3.2 Millimeter
0225-028-514

  • Whole-blood-recovery autotransfusion system, manual

NA - 04546540867186

CBCII Blood Conversion Kit with Quick Disconnect Blood Bag
STRYKER CORPORATION
0225028085
Not in Commercial Distribution

  • 34546540867187 ()
  • 04546540867186 ()
0225-028-085

  • Whole-blood-recovery autotransfusion system, manual

CBCII ConstaVac - 04546540867131

Blood Conservation System
STRYKER CORPORATION
0225028000E
Not in Commercial Distribution

  • 34546540867132 ()
  • 04546540867131 ()
0225-028-000E

  • Closed-wound drain, non-bioabsorbable

InterPulse - 04546540862563

Rechargeable Handpiece Set with Bone Cleaning Tip and Suction Tube
STRYKER CORPORATION
0211110000E
In Commercial Distribution

  • 34546540862564 ()
  • 04546540862563 ()
0211110000E

  • Disposable surgical irrigation/aspiration system

InterPulse - 04546540862532

Rechargeable Handpiece Set with Suction Tubing
STRYKER CORPORATION
0211100000E
In Commercial Distribution

  • 34546540862533 ()
  • 04546540862532 ()
0211100000E

  • Disposable surgical irrigation/aspiration system

Patient Interface Module (PIMr) - 00845225011420

Patient interface module for rotational intravascular ultrasound catheters
Philips Image Guided Therapy Corporation
808884001
In Commercial Distribution

  • 00845225011420 ()
808884001

  • Cardiovascular ultrasound imaging system

IVUS-PIM - 00845225012762

Patient interface module for intravascular ultrasound catheters
Philips Image Guided Therapy Corporation
802143001-ROHS
In Commercial Distribution

  • 00845225012762 ()
802143001-ROHS

  • Cardiovascular ultrasound imaging system

FUJIFILM - 04547410331370

The balloon is intended to be used in combination with Double Balloon Endoscopes to assist with insertion inside the upper or lower digestive tract. This product is not intended for use for any neonates, infants or children.
FUJIFILM CORPORATION
BS-2
In Commercial Distribution

  • 04547410331370 ()
  • 84547410331376 ()
  • 14547410331377 ()


  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

TekCare Green-Type Infrared Thermometer - 04710953421468

The IR Thermometer is intended to be used as the intermittent measurement of human body temperature for people of all ages.
AVITA CORPORATION
NT1G
In Commercial Distribution

  • 04710953421468 ()
  • 04710953421475 ()


  • Infrared patient thermometer, ear

CNAP® Monitor 500 - 09120073931139

SET of: 09120073931146, CNAP® Monitor 500 HD, Main Unit including quick Guide 09120073930118, CNAP® controller set, incl. 09120073930101, CNAP® Controller and 09120073930088, Fixture for CNAP® controller, adapter between 09120073930101 CNAP® Controller and 09120073930361 CNAP® forearm fixing cuff 09120073930361, CNAP® forearm fixing cuff, for fixing 09120073930101 CNAP® Controller 09120073930095, CNAP® cable, 2.5m; interface 09120073930101 CNAP® controller to 09120073931146 CNAP® Monitor 500 HD 09120073930125, CNAP® double finger cuff "large", sensor with Extended Lifecycle (150h) 09120073930163, CNAP® double finger cuff "medium", sensor with Extended Lifecycle (150h) 09120073930200, CNAP® double finger cuff "small", sensor with Extended Lifecycle (150h) 09120073931030, AUX: Analog out connector, connector for data analog output 09120073930033, BP Wave Out: CNAP® transducer cable, Unit; grey; adapter to interface cable 09120073930279, Operator's Manual GERMAN, 09120073930668, CNAP® Component Organizer Set for CNAP® Monitor, 09120073930798 CNAP® double finger cuff mounting bracket together with 09120073930781 CNAP® controller mounting bracket NBP cuffs: 10840935102236, All Purpose Cuff, General, Large Adult, 98-0099-08, 20-FMA-15450 10840935102168, All Purpose Cuff, General, Adult 98-0097-10, 20-FMA-15350 10840935102113, All Purpose Cuff, General, Small Adult, 98-0095-09, 20-FMA-15250 10840935102052, All Purpose Cuff, General, Child, 98-0093-06, 20-FMA-15150 Patient Hose, 3 Meter, Rectus Fittings, 98-0028-00, 20-FMA-05050 Power cord Standard, 20-HEKA-01015, primary cord to external mains adapter External mains adapter, Manufacturer: M+R Multitronik GmbH, Niels-Bohr-Ring 28, 23568 Lübeck, Germany, phone: +49 451 60 99 5 0, 2 pcs. Thermal paper, 20-HVZU-00258
CNSystems Medizintechnik AG
V1.5
Not in Commercial Distribution

  • 09120073931139 ()
21-FHCN-15529

  • Noninvasive haemodynamic monitoring system

CNAP® Monitor 500 - 09120073931122

SET of: 09120073930385, CNAP® Monitor 500, Main Unit including quick Guide 09120073930118, CNAP® controller set, incl. 09120073930101, CNAP® Controller and 09120073930088, Fixture for CNAP® controller, adapter between 09120073930101 CNAP® Controller and 09120073930354 CNAP® forearm fixing cuff 09120073930354, CNAP® forearm fixing cuff, for fixing 09120073930101 CNAP® Controller 09120073930095, CNAP® cable, 2.5m; interface 09120073930101 CNAP® controller to 09120073930385 CNAP® Monitor 500 09120073930156, CNAP® double finger cuff "large", sensor with Unlimited Lifecycle (600h) 09120073930194, CNAP® double finger cuff "medium", sensor with Unlimited Lifecycle (600h) 09120073930231, CNAP® double finger cuff "small", sensor with Unlimited Lifecycle (600h) 09120073931030, AUX: Analog out connector, connector for data analog output 09120073930033, BP Wave Out: CNAP® transducer cable, Unit; grey; adapter to interface cable 09120073930293, Operator's Manual USA, 09120073930668, CNAP® Component Organizer Set for CNAP® Monitor, 09120073930798 CNAP® double finger cuff mounting bracket together with 09120073930781 CNAP® controller mounting bracket NBP cuffs: 10840935102236, All Purpose Cuff, General, Large Adult, 98-0099-08, 20-FMA-15450 10840935102168, All Purpose Cuff, General, Adult 98-0097-10, 20-FMA-15350 10840935102113, All Purpose Cuff, General, Small Adult, 98-0095-09, 20-FMA-15250 10840935102052, All Purpose Cuff, General, Child, 98-0093-06, 20-FMA-15150 Patient Hose, 3 Meter, Rectus Fittings, 98-0028-00, 20-FMA-05050 Power cord USA Standard, 20-HEKA-01017, primary cord to external mains adapter External mains adapter, Manufacturer: M+R Multitronik GmbH, Niels-Bohr-Ring 28, 23568 Lübeck, Germany, phone: +49 451 60 99 5 0, 2 pcs. Thermal paper, 20-HVZU-00258
CNSystems Medizintechnik AG
V1.5
Not in Commercial Distribution

  • 09120073931122 ()
21-FHCN-15527

  • Noninvasive haemodynamic monitoring system

CNAP® Monitor 500 - 09120073931115

SET of: 09120073930385, CNAP® Monitor 500, Main Unit including quick Guide 09120073930118, CNAP® controller set, incl. 09120073930101, CNAP® Controller and 09120073930088, Fixture for CNAP® controller, adapter between 09120073930101 CNAP® Controller and 09120073930354 CNAP® forearm fixing cuff 09120073930354, CNAP® forearm fixing cuff, for fixing 09120073930101 CNAP® Controller 09120073930095, CNAP® cable, 2.5m; interface 09120073930101 CNAP® controller to 09120073930385 CNAP® Monitor 500 09120073930132, CNAP® double finger cuff "large", sensor with Maximum Lifecycle (300h) 09120073930170, CNAP® double finger cuff "medium", sensor with Maximum Lifecycle (300h)) 09120073930217, CNAP® double finger cuff "small", sensor with Maximum Lifecycle (300h) 09120073931030, AUX: Analog out connector, connector for data analog output 09120073930033, BP Wave Out: CNAP® transducer cable, Unit; grey; adapter to interface cable 09120073930293, Operator's Manual USA, 09120073930668, CNAP® Component Organizer Set for CNAP® Monitor, 09120073930798 CNAP® double finger cuff mounting bracket together with 09120073930781 CNAP® controller mounting bracket NBP cuffs: 10840935102236, All Purpose Cuff, General, Large Adult, 98-0099-08, 20-FMA-15450 10840935102168, All Purpose Cuff, General, Adult 98-0097-10, 20-FMA-15350 10840935102113, All Purpose Cuff, General, Small Adult, 98-0095-09, 20-FMA-15250 10840935102052, All Purpose Cuff, General, Child, 98-0093-06, 20-FMA-15150 Patient Hose, 3 Meter, Rectus Fittings, 98-0028-00, 20-FMA-05050 Power cord USA Standard, 20-HEKA-01017, primary cord to external mains adapter External mains adapter, Manufacturer: M+R Multitronik GmbH, Niels-Bohr-Ring 28, 23568 Lübeck, Germany, phone: +49 451 60 99 5 0, 2 pcs. Thermal paper, 20-HVZU-00258
CNSystems Medizintechnik AG
V1.5
Not in Commercial Distribution

  • 09120073931115 ()
21-FHCN-15526

  • Noninvasive haemodynamic monitoring system
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