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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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MonitAir - 00198168370179

MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
Monitair LLC
1.2.6
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only

MonitAir - 00198168116760

MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
Monitair LLC
1.2.5
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only

MonitAir - 00198168299500

MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
Monitair LLC
1.2.4
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only

Cross-Fuse PEEK IBF System - 00846468041090

TRIAL CADDY
Pioneer Surgical Technology, Inc.
35-TRLCADDY-L
Not in Commercial Distribution

35-TRLCADDY-L

  • Device sterilization/disinfection container, reusable

Cross-Fuse PEEK IBF System - 00846468041083

TAMP
Pioneer Surgical Technology, Inc.
35-TAMP
Not in Commercial Distribution

35-TAMP

  • Surgical tamp, reusable

Cross-Fuse PEEK IBF System - 00846468041069

INSERTER, MODULAR CLEANING
Pioneer Surgical Technology, Inc.
35-INSERTER2-18-CL
Not in Commercial Distribution

35-INSERTER2-18-CL

  • Orthopaedic inorganic implant inserter/extractor, reusable

Cross-Fuse PEEK IBF System - 00846468040987

INSERTER, MODULAR CLEANING
Pioneer Surgical Technology, Inc.
35-INSERTER-14-CL
Not in Commercial Distribution

35-INSERTER-14-CL

  • Orthopaedic inorganic implant inserter/extractor, reusable

Cross-Fuse PEEK IBF System - 00846468040970

INSERTER
Pioneer Surgical Technology, Inc.
35-INSERTER-14
Not in Commercial Distribution

35-INSERTER-14

  • Orthopaedic inorganic implant inserter/extractor, reusable

Cross-Fuse PEEK IBF System - 00846468040963

TRIAL SPACER
Pioneer Surgical Technology, Inc.
35-DTRL22-9
Not in Commercial Distribution

35-DTRL22-9

  • Surgical implant template, reusable

Cross-Fuse PEEK IBF System - 00846468039349

TRIAL SPACER
Pioneer Surgical Technology, Inc.
35-DTRL22-15
Not in Commercial Distribution

35-DTRL22-15

  • Surgical implant template, reusable
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