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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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EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI (5) NON-CE - 07290019402381

ExAblate 4000 (Neuro) EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI (5) NON-CE The membrane and DQA are for 5 treatment reuse
INSIGHTEC LTD
SET001047 EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI (5) NON-CE
In Commercial Distribution

  • 07290019402381 ()
SET001047

  • Therapeutic oncological/gynaecological ultrasound system

EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE (5) NON-CE - 07290019402343

ExAblate 4000 (Neuro) EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE (5) NON-CE The membrane and DQA are for 5 treatment reuse
INSIGHTEC LTD
SET001045 EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE (5) NON-CE
In Commercial Distribution

  • 07290019402343 ()
SET001045

  • Therapeutic oncological/gynaecological ultrasound system

EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE (5) NON-CE - 07290019402329

ExAblate 4000 (Neuro) EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE (5) NON-CE The membrane and DQA are for 5 treatment reuse
INSIGHTEC LTD
SET001044 EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE (5) NON-CE
In Commercial Distribution

  • 07290019402329 ()
SET001044

  • Therapeutic oncological/gynaecological ultrasound system

Raindrop Near Vision Inlay - 10850394006013

The Raindrop Near Vision Inlay is a biocompatible hydrogel corneal inlay. It is designed to be implanted under a femtosecond laser flap onto the stromal bed of the cornea, centered over a light-constricted pupil. The Raindrop Near Vision Inlay reshapes the central region of the cornea to provide a zone of increased power for focusing on near objects, resulting in improvement in near vision. The Raindrop Near Vision Inlay is supplied steam sterilized and pre-loaded in its delivery device, the Inlay Inserter. It is for single-use only.
REVISION OPTICS, INC.
RD1-1
In Commercial Distribution

  • 10850394006013 ()
  • 20850394006010 ()

  • Diameter
RD1-1

  • Corneal inlay, aperture reducing

B-P TOTAL SHOULDER SYSTEM - 00814193025562

B-P SHOULDER MODULAR SALVAGE HUMERAL STEM W/BIOCOAT & W/ULTRACOAT - SIZE 4
ENDOTEC, INC.
02-21-0204
In Commercial Distribution

  • 00814193025562 ()

  • SIZE 4
02-21-0204

  • Total shoulder prosthesis

B-P TOTAL SHOULDER SYSTEM - 00814193025555

B-P SHOULDER MODULAR SALVAGE HUMERAL STEM W/BIOCOAT & W/ULTRACOAT - SIZE 3
ENDOTEC, INC.
02-21-0203
Not in Commercial Distribution

  • 00814193025555 ()

  • SIZE 3
02-21-0203

  • Total shoulder prosthesis

B-P TOTAL SHOULDER SYSTEM - 00814193025548

B-P SHOULDER MODULAR SALVAGE HUMERAL STEM W/BIOCOAT & W/ULTRACOAT - SIZE 2
ENDOTEC, INC.
02-21-0202
In Commercial Distribution

  • 00814193025548 ()

  • SIZE 2
02-21-0202

  • Total shoulder prosthesis

B-P TOTAL SHOULDER SYSTEM - 00814193025531

B-P SHOULDER MODULAR SALVAGE HUMERAL STEM W/BIOCOAT & W/ULTRACOAT - SIZE 1
ENDOTEC, INC.
02-21-0201
In Commercial Distribution

  • 00814193025531 ()

  • SIZE 1
02-21-0201

  • Total shoulder prosthesis

B-P TOTAL SHOULDER SYSTEM - 00814193025470

B-P SHOULDER SALVAGE HUMERAL STEM W/ BIOCOAT & W/ULTRACOAT - 14 MM
ENDOTEC, INC.
02-04-0614
In Commercial Distribution

  • 00814193025470 ()

  • Outer Diameter: 14 Millimeter
02-04-0614

  • Bipolar humeral head outer component

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
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