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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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PRECICHEK AutoCode Blood Glucose ACH foil packed test strip
HMD BIOMEDICAL INC.
3L-10-16003B
In Commercial Distribution

  • 04260236851210 ()
  • 04260236851142 ()
3L-10-16003B

  • Glucose IVD, kit, electrometry
  • Isocitrate dehydrogenase 2 (IDH2) gene mutation IVD, control
Abbott RealTime IDH2 Amplification Reagent Kit
ABBOTT MOLECULAR INC.
08N82-090
In Commercial Distribution

  • 00884999047044 ()
08N82-090

  • Isocitrate dehydrogenase 2 (IDH2) gene mutation IVD, kit, nucleic acid technique (NAT)
Preci-Sagix Female Combination Package 2+2+2
Alphadent NV
1364
In Commercial Distribution

  • 04260576940827 ()

  • Outer Diameter: 2.2 Millimeter
  • female
1364

  • Sliding dental precision attachment
Box: 2 varnish, 2 paste, 2 DPA's
YOUNG DENTAL MANUFACTURING I, LLC
295548
In Commercial Distribution

  • 10302732955489 ()


  • Dental coating, tooth-desensitizing
Bag: 2 varnish, 2 paste, 2 DPA's
YOUNG DENTAL MANUFACTURING I, LLC
295335
In Commercial Distribution

  • 10302732953355 ()


  • Dental coating, tooth-desensitizing
VIPER 2 SYSTEM CASE 2 TRAY 2
DEPUY SPINE, LLC
286705050
In Commercial Distribution

  • 10705034213583 ()
286705050

  • Instrument tray, reusable
Kelly Retractor 2" x 2 1/2"
Automated Medical Products Corp.
Kelly Retractor 2" x 2 1/2"
In Commercial Distribution

  • 00810118341779 ()
1558 00 SS

  • Surgical retractor/retraction system blade, reusable
2 x 2 x 2 L Plate
OSTEOMED LLC
213-0070
In Commercial Distribution

  • 00845694003353 ()

  • Length: 19 Millimeter
213-0070

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Oxygen Regulator, 0-8 LPM Full Size, CGA 870, Barb Outlet
PROACTIVE MEDICAL PRODUCTS, LLC
PMREG08B
In Commercial Distribution

  • 05060488573194 ()

  • Length: 6 Inch
  • Width: 2 Inch
  • Height: 2 Inch
PMREG08B

  • Oxygen therapy conserving regulator
Oxygen Regulator, Pediatric, 0-4 LPM Full Size, CGA 540, Diss Outlet
PROACTIVE MEDICAL PRODUCTS, LLC
PMREG04D
In Commercial Distribution

  • 05060488573187 ()

  • Length: 6 Inch
  • Width: 2 Inch
  • Height: 2 Inch
PMREG04D

  • Oxygen therapy conserving regulator
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