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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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G-aenial™ - D0470083221

G-aenial™ Flo X AO2
Gc America Inc.
008322
In Commercial Distribution

  • D0470083221 ()

  • Total Volume: 2 Milliliter
008322

  • Dental composite resin

G-aenial™ - D0470083211

G-aenial™ Flo X A4
Gc America Inc.
008321
In Commercial Distribution

  • D0470083211 ()

  • Total Volume: 2 Milliliter
008320

  • Dental composite resin

G-aenial™ - D0470083201

G-aenial™ Flo X A3.5
Gc America Inc.
008320
In Commercial Distribution

  • D0470083201 ()

  • Total Volume: 2 Milliliter
008320

  • Dental composite resin

G-aenial™ - D0470083191

G-aenial™ Flo X A3
Gc America Inc.
008319
In Commercial Distribution

  • D0470083191 ()

  • Total Volume: 2 Milliliter
008319

  • Dental composite resin

G-aenial™ - D0470083181

G-aenial™ Flo X A2
Gc America Inc.
008318
In Commercial Distribution

  • D0470083181 ()

  • Total Volume: 2 Milliliter
008318

  • Dental composite resin

G-aenial™ - D0470083171

G-aenial™ Flo X A1
Gc America Inc.
008317
In Commercial Distribution

  • D0470083171 ()

  • Total Volume: 2 Milliliter
008317

  • Dental composite resin

HYBENX Root Canal Cleanser - 00860004740308

EPIEN Root Canal Cleanser is indicated for use as an adjunctive rinse of tooth root canal systems and adjacent tooth surfaces during standard professional dental procedures to enhance the removal of post-instrumentation dentinal debris and smear-layer within the root canal system.
Epien Medical, Inc.
101-2002
Not in Commercial Distribution

  • 00860004740308 ()

  • Total Volume: 2 Milliliter


  • Dental mouthwash

Myron L® Company - 00857744006221

An accessory for the D-6 Dialysate Meter™. A hard case, foam-lined protective carrying case. Contains 1 (one) each 2 oz bottle of 14.0 millimohs, NaCl Standard Solution (P/N NACL-14.02OZ; UDI# 00857744006108). This is the only listed component included this item. The D-6 Dialysate Meter™ is packaged separately. NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predominately NaCI (sodium chloride), such as Dialysate. It’s FDA Product Code is FKH: Solution, Test Standard, Conductivity, Dialysis.
MYRON L COMPANY
PortaKit for D-6 Digital Dialysate Meter
In Commercial Distribution

  • 00857744006221 ()

  • Total Volume: 2 Fluid Ounce
PKD

  • Haemodialysis conductivity standard solution

Myron L® Company - 00857744006108

NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predominately NaCI (sodium chloride), such as Dialysate. It’s FDA Product Code is FKH: Solution, Test Standard, Conductivity, Dialysis.
MYRON L COMPANY
Solution, NaCl, 14.0 Millimhos, 2 Ounces
In Commercial Distribution

  • 00857744006108 ()

  • Total Volume: 2 Fluid Ounce
NACL-14.02OZ

  • Haemodialysis conductivity standard solution

Vit Kit® - Thaw - 00857515006191

Vitrification Thaw Kit for Embryos Custom for JX
FUJIFILM IRVINE SCIENTIFIC, INC.
90137-JX
In Commercial Distribution

  • 00857515006191 ()

  • Total Volume: 2 Milliliter
90137-JX

  • IVF medium kit
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