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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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U BAR
MEDLINE INDUSTRIES, INC.
DYNJ902374L
In Commercial Distribution

  • 10198459128899 ()
DYNJ902374L

  • General surgical procedure kit, non-medicated, single-use
U Drape
O&M HALYARD, INC.
48069
In Commercial Distribution

  • 90680651480692 ()
  • 30680651480690 ()
48069

  • Patient surgical drape, single-use, non-sterile
U Drape
O&M HALYARD, INC.
48098
In Commercial Distribution

  • 30680651480980 ()
  • 20680651480983 ()
  • 90680651480982 ()
48098

  • Patient surgical drape, single-use, non-sterile
TRIAL (U)
KURARAY NORITAKE DENTAL INC.
#4232-KA
In Commercial Distribution

  • EKUR004232KA1 ()


  • Dental composite resin
PLT (U)
KURARAY NORITAKE DENTAL INC.
#3191-KA
In Commercial Distribution

  • EKUR003191KA0 ()
  • EKUR003191KA1 ()


  • Dental composite resin
Syringe (U)
KURARAY NORITAKE DENTAL INC.
#3181-KA
In Commercial Distribution

  • EKUR003181KA1 ()


  • Dental composite resin
No Description
Boston Brace International, Inc.
SENSOR-MA-V1
In Commercial Distribution

  • 00860013109813 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
The .decimal Astroid Dosimetry App device is used for planning and analysis of proton radiation therapy treatments.
DECIMAL, INC.
1.0
In Commercial Distribution

  • 00851147007076 ()


  • Radiation therapy software
iOS smartphone application for MODD1 Insulin Delivery System, software version v1.X
Modular Medical, Inc.
MODD1 Insulin Delivery System
In Commercial Distribution

  • 00850037806010 ()
MTL-103

  • Ambulatory insulin infusion pump software, patient-dosing
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3537
In Commercial Distribution

  • 00301933537015 ()
85498754

  • Self-care monitoring/reporting software
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