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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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Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 2.9 (Octa) x 4.0 mm (H)
Biotem Co., ltd
SAITB40434
In Commercial Distribution

  • 08800036204104 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 3.1 (Octa) x 7.0 mm (H)
Biotem Co., ltd
SAIT40437
In Commercial Distribution

  • 08800036204098 ()


  • Dental implant system
ARCHITECT HIV Ag/Ab Combo Controls
Abbott GmbH
2P36-10
In Commercial Distribution

  • 00380740003883 ()
02P3610

  • HIV1/HIV2 antigen/antibody IVD, control
ARCHITECT HIV Ag/Ab Combo Calibrator
Abbott GmbH
2P36-01
In Commercial Distribution

  • 00380740003876 ()
02P3601

  • HIV1/HIV2 antigen/antibody IVD, calibrator
Shani Darden Branded Facemask Blue, Red & NIR facemask
I-SMART DEVELOPMENTS LIMITED
TN2118
In Commercial Distribution

  • 05060534510517 ()
115-HGSD

  • Blue/red/infrared phototherapy lamp
PLUG MMT-7736L TEST LOCKOUT 2PK EN
MEDTRONIC MINIMED, INC.
MMT-7736L
In Commercial Distribution

  • 20643169975105 ()
  • 00643169975101 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
ECG Electrodes
Leonhard Lang GmbH
FS-TB1 /5 -5
In Commercial Distribution

  • 39005531592026 ()
  • 29005531592029 ()
  • 19005531592022 ()
  • 09005531592025 ()
FS-TB1 /5 -5

  • Electrocardiographic electrode, single-use
Constriction Ring
AUGUSTA MEDICAL SYSTEMS, L.L.C.
Constriction Ring
In Commercial Distribution

  • 00852598007349 ()


  • Penile vacuum device
Constriction Ring
AUGUSTA MEDICAL SYSTEMS, L.L.C.
Constriction Ring
In Commercial Distribution

  • 00852598007318 ()


  • Penile vacuum device
No Description
Biomedica ADI Inc.
815
In Commercial Distribution

  • 00850201006024 ()
  • 10850201006021 ()
815

  • Lupus anticoagulant marker IVD, kit, clotting
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