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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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BD PrepStain™ Consumables Kit: BD SurePath™ PreCoat Slides (5 X 96), BD PrepStain™ Transfer Tips (5 X 96), & BD Settling Chambers (2 X 240)
TRIPATH IMAGING, INC.
491311
Not in Commercial Distribution

  • 00382904913113 ()
491311

  • Papanicolaou smear kit
ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, 1/2IN X 1IN, 7MM THICK
Integra Lifesciences Corporation
1690-ZZ
In Commercial Distribution

  • 10381780000198 ()
  • 00381780000191 ()
  • M2691690ZZ0 ()

  • 1.27 cm x 2.54 cm x 7.0 mm
  • 1/2 in x 1in x 7.0 mm
1690-ZZ

  • Collagen haemostatic agent, non-antimicrobial
The NeuroPace® Lead Accessory package contains 2 Lead Caps, 4 Suture Sleeves, 1 Stop Gauge, 1 Tunneling Tool, 1 Tunneling Tool Tip and 1 Tunneling Tool Straw.
Neuropace, Inc.
LA-02-K
In Commercial Distribution

  • 00855547005229 ()


  • Brain-responsive electrical stimulation system
OPTIMIZER Lite Implantable Pulse Generator for the Treatment of Heart Failure System consists of: (1) OPTIMIZER Lite Implantable Pulse Generator (IPG) (1) Allen #2 torque wrench (1) Port Plug
Impulse Dynamics (usa) Inc.
Lite
In Commercial Distribution

  • 00810003380142 ()
10-B502-3-XX

  • Cardiac contractility modulation system pulse generator
OPTIMIZER Smart Implantable Pulse Generator for the Treatment of Heart Failure System consists of: (1) OPTIMIZER Smart Implantable Pulse Generator (IPG) (1) Allen #2 torque wrench (1) Port Plug
Impulse Dynamics (usa) Inc.
CCM X10
In Commercial Distribution

  • 00810003380050 ()
10-B411-3-XX

  • Cardiac contractility modulation system pulse generator
OPTIMIZER Smart Implantable Pulse Generator for the Treatment of Heart Failure System consists of: (1) OPTIMIZER Smart Implantable Pulse Generator (IPG) (1) Allen #2 torque wrench (1) Port Plug
Impulse Dynamics (usa) Inc.
CCM X10
In Commercial Distribution

  • 00810003380005 ()
10-B411-3-US

  • Cardiac contractility modulation system pulse generator
The Praxis™ Extended RAS Panel assay is designed specifically for the detection of 56 mutations from exons 2, 3, and 4 of the KRAS and NRAS genes using the Illumina MiSeqDx Instrument. The assay has been configured for 2 runs with a maximum of 10 samples plus 2 controls per run. Illumina provides the following reagents for the Illumina Praxis Extended RAS Panel: 20012195, Praxis Extended RAS Panel – 1/6; 20012196, Praxis Extended RAS Panel – 1A; 20012197, Praxis Extended RAS Panel – 1B; 20012198, Praxis Extended RAS Panel – 2/6; 20012199, Praxis Extended RAS Panel – 3/6; 20012200, Praxis Extended RAS Panel – 3A; 20012201, Praxis Extended RAS Panel – 3B; 20012202, Praxis Extended RAS Panel – 4/6; 20012203, Praxis Extended RAS Panel – 5/6; and 20012204, Praxis Extended RAS Panel – 6/6.
ILLUMINA, INC.
20012431
Not in Commercial Distribution

  • 00816270020088 ()
20012431

  • Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
OPTIMIZER Smart Mini Implantable Pulse Generator for the Treatment of Heart Failure System consists of: (1) OPTIMIZER Smart Mini Implantable Pulse Generator (IPG) (1) Allen #2 torque wrench (1) Port Plug
Impulse Dynamics (usa) Inc.
Smart Mini
In Commercial Distribution

  • 00810003380098 ()
10-B501-3-XX

  • Cardiac contractility modulation system pulse generator
A Kit for 10 Neuro treatments (Master Treatment Kit for 3.0T (SIEMENS) Type 1.1 NonCE/FDA) Kit content: Part Description SET001047 EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI (5) X 2 units
INSIGHTEC LTD
SET001104 Master Treatment Kit for 3.0T (SIEMENS) Type 1.1 NonCE/FDA
In Commercial Distribution

  • 07290015461900 ()
SET001104

  • Therapeutic oncological/gynaecological ultrasound system
A Kit for 10 Neuro treatment (Master Treatment Kit for 1.5T (SIEMENS) Type 1.1 NonCE/FDA). Kit content: Part Description SET001046 EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI (5) X 2 units
INSIGHTEC LTD
SET001103 Master Treatment Kit for 1.5T (SIEMENS) Type 1.1 NonCE/FDA
In Commercial Distribution

  • 07290015461894 ()
SET001103

  • Therapeutic oncological/gynaecological ultrasound system
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