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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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Vision 2 - 00817978020028

Salmonella OMB Group: C, F, G, H
PRO-LAB, INCORPORATED
PLA005
In Commercial Distribution

  • 00817978020028 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

INFINI - 08809447650883

INFINI MFR G U110V (INFINI Radiofrequency System)
Lutronic Corporation
INFINI MFR G U110V
In Commercial Distribution

  • 8809447650944 ()
  • 08809447650883 ()


  • Radio-frequency skin surface treatment system

BLUE AND GREEN - 00840018649422

B&G PROBE 3-6-8-11 MM SINGLE END
NORDENT MANUFACTURING INC
P8-11/BG
In Commercial Distribution

  • 00840018649422 ()


  • Periodontal probe, reusable

BLUE AND GREEN - 00840018649415

B&G PROBE 2 MM SINGLE END
NORDENT MANUFACTURING INC
P22/BG
In Commercial Distribution

  • 00840018649415 ()


  • Periodontal probe, reusable

MTA Capsules - 17540208000391

Endodontic repair cement - Universal; 0.3 g capsules
Zendo Direct AG
ZEN-MTA-UNI
In Commercial Distribution

  • 27540208000398 ()
  • 17540208000391 ()
  • 07540208000394 ()
ZEN-MTA-UNI

  • Endodontic filling/sealing material

Lumipulse G BHCG Calibrators - 04987270231111

No Description
FUJIREBIO INC.
231111
In Commercial Distribution

  • 04987270231111 ()

  • Size Type = Units per Kit; Units = 2; Unit of Measure = 3.0mLs


  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, calibrator

physIQ Patient Kit - 00850023120038

physIQ convenience kit including re-supply of biosensors and skin preparation materials.
PHYSIQ, INC
Model G
In Commercial Distribution

  • 00850023120038 ()


  • Electrocardiography telemetric monitoring system

KALORE™ - D0470035971

KALORE™ Syringes (2 mL/4 g) CVT
Gc America Inc.
003597
In Commercial Distribution

  • D0470035971 ()

  • Total Volume: 2 Milliliter
003597

  • Light-cured dental restorative composite resin

KALORE™ - D0470035961

KALORE™ Syringes (2 mL/4 g) GT
Gc America Inc.
003596
In Commercial Distribution

  • D0470035961 ()

  • Total Volume: 2 Milliliter
003596

  • Light-cured dental restorative composite resin

KALORE™ - D0470035951

KALORE™ Syringes (2 mL/4 g) NT
Gc America Inc.
003595
In Commercial Distribution

  • D0470035951 ()

  • Total Volume: 2 Milliliter
003595

  • Light-cured dental restorative composite resin
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