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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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APO CAL - 05055273204414

This product is intended for in-vitro use in the calibration of Apolipoprotein A-I and Apolipoprotein B assays.
RANDOX LABORATORIES LIMITED
LP3023
In Commercial Distribution

  • 05055273204414 ()
LP3023

  • Multiple apolipoprotein IVD, calibrator

Sontro Self-Fitting OTC Hearing Aids - 00850016231161

BEIGE/990016-SWH; right (refurbished) replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990016-SWH
In Commercial Distribution

  • 00850016231161 ()


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

Sontro Self-Fitting OTC Hearing Aids - 00850016231086

GREY/990008-SWH; left (refurbished) replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990008-SWH
In Commercial Distribution

  • 00850016231086 ()


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

Sontro Self-Fitting OTC Hearing Aids - 00850016231079

GREY/990007-SWH; right (refurbished) replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990007-SWH
In Commercial Distribution

  • 00850016231079 ()


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

Sontro Self-Fitting OTC Hearing Aids - 00850016231178

BEIGE/990017-SWH; left (refurbished) replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990017-SWH
In Commercial Distribution

  • 00850016231178 ()


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

Crypto/Giardia Human Fecal Direct Fluorescent Antigen Detection Kit - 00854624006005

No Description
IVD RESEARCH, INC.
C/G-DFA
In Commercial Distribution

  • 00854624006005 ()
C/G-DFA

  • Cryptosporidium species antigen IVD, kit, direct fluorescent test (DFT)
  • Giardia lamblia antigen IVD, kit, direct fluorescent test (DFT)

QUANTUM™* FLEX - 00846468022471

ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-90
Not in Commercial Distribution

  • 00846468022471 ()


  • Bone-screw internal spinal fixation system, non-sterile

QUANTUM™* FLEX - 00846468022464

ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-80
Not in Commercial Distribution

  • 00846468022464 ()


  • Bone-screw internal spinal fixation system, non-sterile

QUANTUM™* FLEX - 00846468022457

ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-70
Not in Commercial Distribution

  • 00846468022457 ()


  • Bone-screw internal spinal fixation system, non-sterile

QUANTUM™* FLEX - 00846468022440

ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-60
Not in Commercial Distribution

  • 00846468022440 ()


  • Bone-screw internal spinal fixation system, non-sterile
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