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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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B-P TOTAL SHOULDER SYSTEM - 00814193025463

B-P SHOULDER SALVAGE HUMERAL STEM W/ BIOCOAT & W/ULTRACOAT - 12 MM
ENDOTEC, INC.
02-04-0612
In Commercial Distribution

  • 00814193025463 ()

  • Outer Diameter: 12 Millimeter
02-04-0612

  • Bipolar humeral head outer component

B-P TOTAL SHOULDER SYSTEM - 00814193025456

B-P SHOULDER SALVAGE HUMERAL STEM W/ BIOCOAT & W/ULTRACOAT - 10 MM
ENDOTEC, INC.
02-04-0610
In Commercial Distribution

  • 00814193025456 ()

  • Outer Diameter: 10 Millimeter
02-04-0610

  • Bipolar humeral head outer component

B-P TOTAL SHOULDER SYSTEM - 00814193025449

B-P SHOULDER SALVAGE HUMERAL STEM W/ BIOCOAT & W/ULTRACOAT - 8 MM
ENDOTEC, INC.
02-04-0608
In Commercial Distribution

  • 00814193025449 ()

  • Outer Diameter: 8 Millimeter
02-04-0608

  • Bipolar humeral head outer component

EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL (5) NON-CE - 07290019402305

ExAblate 4000 (Neuro) EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL (5) NON-CE The membrane and DQA are for 5 treatment reuse
INSIGHTEC LTD
SET001043 EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL (5) NON-CE
In Commercial Distribution

  • 07290019402305 ()
SET001043

  • Therapeutic oncological/gynaecological ultrasound system

EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL SU - 07290019402213

EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL SU w/PFK for 1 treatment PFK package served ETO-sterile
INSIGHTEC LTD
SET001117-SU (w/ PFK) EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL SU
In Commercial Distribution

  • 07290019402213 ()
SET001117-SU

  • Therapeutic oncological/gynaecological ultrasound system

EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL - 07290019402206

EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL w/PFK for 5 treatments PFK package served ETO-sterile
INSIGHTEC LTD
SET001117 (w/ PFK) EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL
In Commercial Distribution

  • 07290019402206 ()
SET001117

  • Therapeutic oncological/gynaecological ultrasound system

EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI SU - 07290019402190

EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI SU w/PFK for 1 treatment for Siemens MR PFK package served ETO-sterile
INSIGHTEC LTD
SET001116-SU (w/ PFK) EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI SU
In Commercial Distribution

  • 07290019402190 ()
SET001116-SU

  • Therapeutic oncological/gynaecological ultrasound system

EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI - 07290019402183

EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI w/PFK for 5 treatments for Siemens MR PFK package served ETO-sterile
INSIGHTEC LTD
SET001116 (w/ PFK) EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI
In Commercial Distribution

  • 07290019402183 ()
SET001116

  • Therapeutic oncological/gynaecological ultrasound system

EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE SU - 07290019402176

EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE SU w/PFK for 1 treatment for GE MR PFK package served ETO-sterile
INSIGHTEC LTD
SET001115-SU (w/ PFK) EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE SU
In Commercial Distribution

  • 07290019402176 ()
SET001115-SU

  • Therapeutic oncological/gynaecological ultrasound system

EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE - 07290019402169

EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE w/PFK for 5 treatments for GE MR PFK package served ETO-sterile
INSIGHTEC LTD
SET001115 (w/ PFK) EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE
In Commercial Distribution

  • 07290019402169 ()
SET001115

  • Therapeutic oncological/gynaecological ultrasound system
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