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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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Beurer - 00850003500478

Beurer Fertility Convenience Kit with Pearl App Each kit contains: 15 FSH test strips, 15 LH test strips, 2 hCG test strips (pregnancy test), Access (activation code) for the Pearl Fertility App.
BEURER NORTH AMERICA, L.P.
OT80
In Commercial Distribution

  • 00850003500478 ()
  • 10850003500475 ()
  • 20850003500472 ()
792.97

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
  • Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing

NexxZr™ T / W-98-35-NT-C400-SD - 00842271104731

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
W-32143
Not in Commercial Distribution

  • 00842271104731 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ T / W-98-30-NT-C400-SD - 00842271104724

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
W-32142
Not in Commercial Distribution

  • 00842271104724 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ T / W-98-26-NT-C400-SD - 00842271104717

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
W-32141
Not in Commercial Distribution

  • 00842271104717 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ T / W-98-35-NT-C300-SD - 00842271104625

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
W-32132
Not in Commercial Distribution

  • 00842271104625 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ T / W-98-30-NT-C300-SD - 00842271104618

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
W-32131
Not in Commercial Distribution

  • 00842271104618 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ T / W-98-26-NT-C300-SD - 00842271104601

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
W-32130
Not in Commercial Distribution

  • 00842271104601 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ T / W-98-35-NT-B300-SD - 00842271104182

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
W-32088
Not in Commercial Distribution

  • 00842271104182 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ T / W-98-30-NT-B300-SD - 00842271104175

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
W-32087
Not in Commercial Distribution

  • 00842271104175 ()


  • Dental appliance fabrication material, ceramic

NexxZr™ T / W-98-35-NT-B100-SD - 00842271103963

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
W-32066
Not in Commercial Distribution

  • 00842271103963 ()


  • Dental appliance fabrication material, ceramic
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