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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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No Description
BLINK MEDICAL LIMITED
67-0010
In Commercial Distribution

  • 05060745558070 ()
  • 05060745558063 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
No Description
BLINK MEDICAL LIMITED
67-0014
In Commercial Distribution

  • 05060745557721 ()
  • 05060745557714 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600436-001
In Commercial Distribution

  • J00716004360011 ()
1600436-001

  • Dental power tool system handpiece, remotely-driven
Dental impression material mixer, Brand Kulzer GmbH
Renfert GmbH
2562001000
In Commercial Distribution

  • J00925620010000 ()
2562001000

  • Dental impression material mixer
Multi Position Stander
RIFTON EQUIPMENT
S420
In Commercial Distribution

  • 00850001752350 ()


  • Manual stander
VitalScreen is an in vitro diagnostic kit for the semi-quantitative determination of human sperm vitality by dye exclusion. The kit consist of 20ml of 1% Eosin Y in saline (product code: VITAL_1 and 30ml of 5% Nigrosin in saline (product code: VITAL_2). The eosin-nigrosin staining technique is based on the principle that dead cells will take up the eosin and as a result stain red. The nigrosin provides a dark background which makes it easier to assess the slides. The VitalScreen™ is based on the test procedure described in the WHO laboratory manual (2010). VitalScreen™ has a 24 month shelf life from date of produce. Reference is made to the product page of VitalScreen on the FertiPro website: www.fertipro.com
Fertipro NV
VITAL_2
In Commercial Distribution

  • 05411967001774 ()

  • Total Volume: 30 Milliliter


  • Biological stain IVD
No Description
BIOCARE MEDICAL LLC
OPRI6045T60
In Commercial Distribution

  • 00847627025005 ()


  • Immunohistochemistry antibody detection IVD, reagent
No Description
SEKISUI DIAGNOSTICS, LLC
SM-056
Not in Commercial Distribution

  • 00628063400461 ()
  • 10628063400468 ()
SM-056

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
W.H. Holden, Inc.
10-4547
In Commercial Distribution

  • D9281045470 ()


  • Dental elevator, tooth/root
No Description
W.H. Holden, Inc.
10-4002DLC
In Commercial Distribution

  • D928104002DLC0 ()


  • Dental elevator, tooth/root
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