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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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N'VISION® - 00643169427037

SW 8870MMC01 NVISION INTSTM ENTERRA2 US
MEDTRONIC, INC.
8870MMC01
In Commercial Distribution

  • 00643169427037 ()


  • Multiple active implantable device programmer

N'VISION® - 00613994606846

SFTWR 8870MMB US MKT MMB/02 BOWEL
MEDTRONIC, INC.
8870MMB02
In Commercial Distribution

  • 00613994606846 ()


  • Multiple active implantable device programmer

N'VISION® - 00613994572783

SFTWR 8870MMB N'VISION US MKT v2.0
MEDTRONIC, INC.
8870
In Commercial Distribution

  • 00613994572783 ()


  • Multiple active implantable device programmer

Head Frame Set for Type 1.1 Systems FDA/ROW - 07290019402237

INSIGHTEC-MADE Head Frame Set for Type 1.1 Systems FDA/ROW. multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment
INSIGHTEC LTD
SET400168-BD Head Frame Set for Type 1.1 Systems FDA/ROW
In Commercial Distribution

  • 07290019402237 ()
SET400168-BD

  • Therapeutic oncological/gynaecological ultrasound system

Head Frame Set for Type 1.0 Systems FDA/ROW - 07290019402220

INSIGHTEC-MADE Head Frame Set for Type 1.0 Systems FDA/ROW. multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment
INSIGHTEC LTD
SET400168-BC Head Frame Set for Type 1.0 Systems FDA/ROW
In Commercial Distribution

  • 07290019402220 ()
SET400168-BC

  • Therapeutic oncological/gynaecological ultrasound system

ExAblate 2100V1 Pelvic RF Coil for 1.5T Artist MR - 07290015461481

PHASE ARRAY ASSY Pelvic RF Coil for MRI imaging during Body FUS treatments. Contains Upper and Lower part: ASM000426-AA - UPPER PELVIC COIL PHASE ARRAY ASSY ASC001361-AR - LOWER PELVIC COIL PHASE ARRAY ASSY for ExAblate 2100V1 under Artist MR guidance
INSIGHTEC LTD
OPT000037-AR ExAblate 2100V1 Pelvic RF Coil for Body
In Commercial Distribution

  • 07290015461481 ()
OPT000037-AR

  • Therapeutic oncological/gynaecological ultrasound system

Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear - 18500071350237

Kit containing 850007135072 (Emerald Toric, opirfocon A, Blue) and 850007135089 (Emerald Toric, oprifocon A, Green)
Euclid Vision Corporation
Emerald Toric
Not in Commercial Distribution

  • 85000713599960 ()
  • 18500071350237 ()


  • Orthokeratology contact lens

Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear - 18500071350220

Kit containing 850007135058 (Emerald Toric, oprifocon A, blue) and 850007135065 (Emerald Toric, oprifocon A, green)
Euclid Vision Corporation
Emerald Toric
Not in Commercial Distribution

  • 85000713599977 ()
  • 18500071350220 ()


  • Orthokeratology contact lens

Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear - 18500071350213

Kit containing 850007135027 (Emerald, oprifocon A, Blue) and 850007135034 (Emerald, oprifocon A, Green)
Euclid Vision Corporation
Emerald
Not in Commercial Distribution

  • 85000713599984 ()
  • 18500071350213 ()


  • Orthokeratology contact lens

Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear - 18500071350206

Kit containing 850007135003 (Emerald, oprifocon A, Blue) and 850007135010 (Emerald, oprifocon A, Green)
Euclid Vision Corporation
Emerald
Not in Commercial Distribution

  • 85000713599991 ()
  • 18500071350206 ()


  • Orthokeratology contact lens
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