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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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DURAY - 00990010301306

DURAY V2, DC Intraoral X-Ray, 60kV & 70kV, 100-230V, 50/60 Hz, 80cm arm length
Beyes Dental Canada Inc
XR2011
In Commercial Distribution

  • 00990010301306 ()
DURAY V2

  • Stationary intraoral dental x-ray system, digital

DURAY - 00990010301283

DURAY V2, MOBILE DC Intraoral X-Ray, 60kV & 70kV, 100-230V, 50/60 Hz, 80cm arm length
Beyes Dental Canada Inc
XR2012
In Commercial Distribution

  • 00990010301283 ()
DURAY V2

  • Stationary intraoral dental x-ray system, digital

Thyretain - 30014613331605

Thretain TSI Reporter Bioassay 50P
DIAGNOSTIC HYBRIDS, INC.
Thyretain
In Commercial Distribution

  • 30014613331605 ()
40-50000.V2

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay

Thyretain - 30014613331537

Thretain TSI Reporter Bioassay 25P
DIAGNOSTIC HYBRIDS, INC.
Thyretain
In Commercial Distribution

  • 30014613331537 ()
40-25000.V2

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay

ELVIS - 30014613336334

ELVIS HSV ID/TYPING TEST SYSTEM
DIAGNOSTIC HYBRIDS, INC.
ELVIS HSV ID / D3 Typing Test System
In Commercial Distribution

  • 30014613336334 ()
SKT-ELVIS-60.V2

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay

ELVIS - 30014613336327

ELVIS HSV ID/TYPING TEST SYSTEM
DIAGNOSTIC HYBRIDS, INC.
ELVIS HSV ID / D3 Typing Test System
In Commercial Distribution

  • 30014613336327 ()
SKT-ELVIS-300.V2

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay

OtoNova Battery Assembly Service Kit - 05060396172809

OtoNova V1/V2/Pro Battery Assembly Service Kit (for authorised dealers/repair centers only)
OTODYNAMICS LIMITED
ON-BATT-KIT
In Commercial Distribution

  • 05060396172809 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer

North American Kandyway Eternal Glow MD-Face - 00628011719911

North American Kandyway Eternal Glow MD - Face (V2 Facemask) Legal Manufacturer- I-Smart Developments Ltd
I-SMART DEVELOPMENTS LIMITED
TN19G
In Commercial Distribution

111B

  • Cosmetic red-light phototherapy system, home-use

De Mayo V2® Knee Positioner® - 00696588007564

De Mayo V2® Knee Positioner® (25" w/ 180° Flip Handle Assembly & 621)
Innovative Medical Products, Inc
114-S-621 KIT
In Commercial Distribution

  • 00696588007564 ()
114-S-621 KIT

  • Leg procedure positioner

De Mayo V2® Knee Positioner® - 00696588007373

De Mayo V2® Knee Positioner® (30" w/ Spring Handle Assembly, 621 & 907-GP-10)
Innovative Medical Products, Inc
114-621 KIT-SHA-P
In Commercial Distribution

  • 00696588007373 ()
114-621 KIT-SHA-P

  • Leg procedure positioner
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