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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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20cm Flexible Probe with Eye - 05060267130716

No Description
XIROS LTD
202-3008
Not in Commercial Distribution

  • 05060267130716 ()
n/a

  • Exploratory blunt needle, single-use

Hemasorb 1.0 gram with Spatula - 00850391007139

Product Box also contain OS-SPA DI 00850391007146
ABYRX, INC.
OS-101
In Commercial Distribution

  • 00850391007160 ()
  • 00850391007139 ()


  • Bone wax, synthetic

Hemasorb 2.0 gram with Spatula - 00850391007023

Product Box also contains OS-SPA DI 00850391007146
ABYRX, INC.
OS-201
In Commercial Distribution

  • 00850391007153 ()
  • 00850391007023 ()


  • Bone wax, synthetic

Universal Dual Swivel with Straps - 00858409005603

No Description
Medicomp
MC-4425
In Commercial Distribution

  • 10858409005600 ()
  • 00858409005603 ()
MC-4425

  • Straight/elbow breathing circuit connector, single-use

C02 Sampling Adapter with Cap - 00858409005382

No Description
Medicomp
MC-6605
In Commercial Distribution

  • 10858409005389 ()
  • 00858409005382 ()
MC-6605

  • Anaesthesia breathing circuit, single-use

Archimedies Access Kit with Syringe - 00856571007234

A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy.
BRONCUS MEDICAL INC.
12196-09
In Commercial Distribution

  • 00856571007234 ()
10009-09

  • Lung biopsy procedure kit

Chang Medium MF with Gentamicin - 00857515006160

No Description
FUJIFILM IRVINE SCIENTIFIC, INC.
91005-500ML
In Commercial Distribution

  • 00857515006160 ()

  • Total Volume: 500 Milliliter
91005

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent

Chang Medium BMC with Gentamicin - 00857515006153

Chang Medium BMC with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
91004-500ML
In Commercial Distribution

  • 00857515006153 ()

  • Total Volume: 500 Milliliter
91004

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent

Respire Pink EF+ with DentiTrac - 00851861007246

Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring.
RESPIRE MEDICAL HOLDINGS LLC
SPPD030US
Not in Commercial Distribution

  • 00851861007246 ()

  • Circumference: 200 Millimeter


  • Mandible-repositioning sleep-disordered breathing orthosis

Respire Pink+ Hard with DentiTrac - 00851861007222

Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring.
RESPIRE MEDICAL HOLDINGS LLC
SPPD000US
Not in Commercial Distribution

  • 00851861007222 ()

  • Circumference: 200 Millimeter


  • Mandible-repositioning sleep-disordered breathing orthosis
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