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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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Reconstitution Buffer, 10% Albumin in Tris buffered solution, antimicrobial agent (800 mL)
EXACT SCIENCES CORPORATION
100542
In Commercial Distribution

  • 00850057859034 ()


  • Faecal occult blood IVD, reagent
Binding Solution, Guanidine Hydrochloride, Citric Acid, Sodium Citrate Tribase Dihydrate (10 L)
EXACT SCIENCES CORPORATION
100700
In Commercial Distribution

  • 00850057859027 ()


  • Nucleic acid extraction/isolation kit IVD
MOPS Buffer, NaCl (20L)
EXACT SCIENCES CORPORATION
100518
In Commercial Distribution

  • 00850057859010 ()


  • Nucleic acid extraction/isolation kit IVD
Magnetic particles with covalently bound oligonucleotide probes (400 mL x 20 ea)
EXACT SCIENCES CORPORATION
100699
In Commercial Distribution

  • 00850057859003 ()


  • Nucleic acid extraction/isolation kit IVD
Adhesive Electrode Patch (ES-2) (900-00031)
Element Science, Inc.
ES-2
In Commercial Distribution

  • 00850047782090 ()
JWL1-PTCH-K-01

  • Wearable defibrillation system defibrillator
ES-2 Starter Kit, Finished, Packaged (Hair Trimmer, Placement Accessory, Adhesive Sheets, Patient Guide) (900-00036)
Element Science, Inc.
ES-2
In Commercial Distribution

  • 00850047782038 ()
JWL1-STRT-K-01

  • Wearable defibrillation system defibrillator
ES-2 Reusable Defibrillator Unit, Packaged (900-00032)
Element Science, Inc.
ES-2
In Commercial Distribution

  • 00850047782007 ()
JWL1-MDU0-E-01

  • Wearable defibrillation system defibrillator
Electrode Covers
Xstim, Inc
07-5001
In Commercial Distribution

  • 00850047248091 ()


  • Patient-worn bone growth electromagnetic stimulator
Xstim Power Supply
Xstim, Inc
07-5005
In Commercial Distribution

  • 00850047248084 ()


  • Patient-worn bone growth electromagnetic stimulator
Xstim Belt Clip
Xstim, Inc
07-5004
In Commercial Distribution

  • 00850047248077 ()


  • Patient-worn bone growth electromagnetic stimulator
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