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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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Vital Signs™ - 10889483585931

Vital Signs™ 300-series ECG Care Cable, 5-lead, AHA, 3 m/ 10 ft
AirLife Finland Oy
545303-HEL
In Commercial Distribution

545303-HEL

  • Electrocardiographic lead set, reusable

Vital Signs™ - 10889483585924

Vital Signs™ 300-series ECG Care Cable, 3-lead, AHA, 3 m/ 10 ft
AirLife Finland Oy
545302-HEL
In Commercial Distribution

545302-HEL

  • Electrocardiographic lead set, reusable

Vital Signs™ - 10889483585917

Vital Signs™ 300-series ECG Care Cable, 5-lead, IEC, 3 m/ 10 ft
AirLife Finland Oy
545301-HEL
In Commercial Distribution

545301-HEL

  • Electrocardiographic lead set, reusable

Lexie B1, Powered by Bose - 00850022464492

Lexie B1 Hearing Aids, powered by Bose. Self-fit, app-controlled hearing aids
HEARX GROUP (PTY) LTD
LB1001
In Commercial Distribution

Online

  • Air-conduction hearing aid, receiver-in-canal

NIGHTTIME -REP - 00850007728335

REPLACEMENT ALIGNERS
Access Dental Lab, LLC
100-0365
In Commercial Distribution



  • Orthodontic progressive aligner

NIGHTTIME ALIGNERS - REF - 00850007728328

REFINEMENT ALIGNERS
Access Dental Lab, LLC
100-0364
In Commercial Distribution



  • Orthodontic progressive aligner

NIGHTTIME ALIGNERS-MCC - 00850007728311

MID-COURSE CORRECTION
Access Dental Lab, LLC
100-0363
In Commercial Distribution



  • Orthodontic progressive aligner

NIGHTTIME CLEAR ALIGNERS - 00850007728304

SEQUENTIAL ALIGNERS- INITIAL
Access Dental Lab, LLC
100-0362
In Commercial Distribution



  • Orthodontic progressive aligner

SDC Aligners-REP - 00850007728298

REPLACEMENT ALIGNERS
Access Dental Lab, LLC
100-0355
In Commercial Distribution



  • Orthodontic progressive aligner

SDC Aligners-REF - 00850007728281

REFINEMENT CORRECTION
Access Dental Lab, LLC
100-0012
In Commercial Distribution



  • Orthodontic progressive aligner
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