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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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NeoBeat is a heart rate measurement device using dry-electrode technology, with integrated digital display.
Laerdal Medical AS
532-01001
In Commercial Distribution

  • 07045432118322 ()
532-01001

  • Wearable neonatal heart rate meter
NeoBeat is a heart rate measurement device using dry-electrode technology, with integrated digital display.
Laerdal Medical AS
531-01001
In Commercial Distribution

  • 07045432118308 ()
531-01001

  • Wearable neonatal heart rate meter
NeoBeat is a heart rate measurement device using dry-electrode technology, with integrated digital display.
Laerdal Medical AS
532-00001
In Commercial Distribution

  • 07045432112511 ()
532-00001

  • Wearable neonatal heart rate meter
TDA is a reagent associated to API 20 E (20 100/20 160), API® 10 S (10 100)
BIOMERIEUX SA
70402
In Commercial Distribution

  • 03573026099596 ()


  • Multiple Enterobacteriaceae species culture isolate identification IVD, reagent
No Description
Baylis Médicale Cie Inc
PSZ-400-311
Not in Commercial Distribution

  • 00685447001751 ()


  • Arthroscopic surgical procedure kit, non-medicated, single-use
Contains one 10858086006280 Cranial Screws, Case of 10 Boxes of 2 Short + 2 Long and one 00858086006252 Headframe Kit
VARIAN MEDICAL SYSTEMS, INC.
P1006805005
In Commercial Distribution

  • 00858086006306 ()


  • Stereotactic radiosurgical invasive head frame
No Description
Biomet Orthopedics, LLC
P3720
In Commercial Distribution

  • 08426750031361 ()
P3720

  • Orthopaedic bone staple, non-adjustable
Child Bib Apron With Collar .3mm Shimmering Green20" X 20"
Flow X Ray Corporation
75053-38
In Commercial Distribution

  • 00812045038784 ()


  • Patient radiation shielding pad/drape, reusable
Software, Opal Acquire Image Acquisition Software.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ-04-01-00-000
In Commercial Distribution

  • 00817100020414 ()


  • Diagnostic x-ray digital imaging system workstation application software
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801847 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
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