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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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NexxZr™ S / Z-95-20-NS-C200-SD - 00842271100061

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-42116
Not in Commercial Distribution

  • 00842271100061 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ S / Z-95-18-NS-C200-SD - 00842271100054

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-42115
Not in Commercial Distribution

  • 00842271100054 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ S / Z-95-16-NS-C200-SD - 00842271100047

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-42114
Not in Commercial Distribution

  • 00842271100047 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ S / Z-95-14-NS-C200-SD - 00842271100030

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-42113
Not in Commercial Distribution

  • 00842271100030 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ S / Z-95-35-NS-C100-SD - 00842271100009

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-42110
Not in Commercial Distribution

  • 00842271100009 ()


  • Dental appliance fabrication material, ceramic

BlackBox RPM - B963BPM201W1

Blood Pressure monitor designed to be used seamlessly with our proprietary hub or mobile app.
Blackbox Remote Patient Monitoring LLC
BPM-201W
Not in Commercial Distribution

  • B963BPM201W1 ()
  • BB1BB963201W1 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

EBM - 04719878879989

No Description
EBM TECHNOLOGIES INCORPORATED
MobiPACS" App 1.2.1, Rad@
In Commercial Distribution

  • 04719878879989 ()


  • Radiological PACS software

Empatica Health Monitoring Platform - 00853858006256

No Description
EMPATICA SRL
Care App Android Version
In Commercial Distribution

  • 00853858006256 ()


  • Multiple vital physiological parameter monitoring system, home-use

GoCheck - B43056000011000

Mobile Application for Hearing Screening
Gobiquity, Inc.
Hearing Mobile App V1.0.0
In Commercial Distribution

  • B43056000011000 ()


  • Tone audiometer

TPH®3 flow Liquid Micro Hybrid - D0026427151

TPH®3 flow Liquid Micro Hybrid Compula® Tip Introductory Kit
DENTSPLY INTERNATIONAL INC.
642715
Not in Commercial Distribution

  • D0026427151 ()

  • Total Volume: 0.125 Milliliter
  • 20 Compula® Tips-5 each shade A1, A2, A3, A3.5 (0.25g each), 20 Adhesive Unit Doses, 1 Syringe Tooth Cond Gel, 1 Compules® Tips Gun, 1 Unit Dose Holder, 25 App Needles, 50 App Tips
  • Weight: 0.25 Gram
642715

  • Dental composite resin
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