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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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Renamel® Microhybrid - EDEL6061B20

Renamel® Microhybrid Body B2, Syringe 5g
DeltaMed GmbH
6061B2
In Commercial Distribution

6061B2

  • Dental composite resin

Renamel® Microhybrid - EDEL6061A30

Renamel® Microhybrid Body A3, Syringe 5g
DeltaMed GmbH
6061A3
In Commercial Distribution

6061A3

  • Dental composite resin

Renamel® Microhybrid - EDEL6061A20

Renamel® Microhybrid Body A2, Syringe 5g
DeltaMed GmbH
6061A2
In Commercial Distribution

6061A2

  • Dental composite resin

Renamel® Microhybrid - EDEL6061A10

Renamel® Microhybrid Body A1, Syringe 5g
DeltaMed GmbH
6061A1
In Commercial Distribution

6061A1

  • Dental composite resin

Insure® Lite Automix - EDEL605ACL0

Insure® Lite Automix, Syringe 8g
DeltaMed GmbH
605ACL
In Commercial Distribution

605ACL

  • Dental composite resin

Insure® Lite - EDEL6051080

Insure® Lite Simulcure Catalyst, Syringe 3g
DeltaMed GmbH
605108
Not in Commercial Distribution

605108

  • Dental composite resin

Insure® Lite - EDEL6051060

Insure® Lite Yellow Opaque, Syringe 3g
DeltaMed GmbH
605106
Not in Commercial Distribution

605106

  • Dental composite resin

Insure® Lite - EDEL6051040

Insure® Lite Grey Light, Syringe 3g
DeltaMed GmbH
605104
Not in Commercial Distribution

605104

  • Dental composite resin

Onyx HD 500 - 00836462005129

105-8101-500 ONYX HD500 KIT ANEURYS
Micro Therapeutics, Inc.
105-8101-500
In Commercial Distribution

  • 00836462005129 ()


  • Neurovascular embolization plug

Ipana 5% Sodium Fluoride Varnish - Melon - 00060705405333

No Description
MAXILL, INC.
40533
In Commercial Distribution

  • 00060705405333 ()
  • 90060705405336 ()


  • Dental cavity varnish
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