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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No Description
MICK RADIO NUCLEAR INSTRUMENT, INC
9102-EZ-20-S
In Commercial Distribution

  • 00817330025319 ()
9102-EZ-20-S

  • General-purpose brachytherapy system applicator, manual
No Description
MICK RADIO NUCLEAR INSTRUMENT, INC
9102-EZ-19-S
In Commercial Distribution

  • 00817330025296 ()
9102-EZ-19-S

  • General-purpose brachytherapy system applicator, manual
No Description
MICK RADIO NUCLEAR INSTRUMENT, INC
9102-EZ-18-S
In Commercial Distribution

  • 00817330025272 ()
9102-EZ-18-S

  • General-purpose brachytherapy system applicator, manual
No Description
MICK RADIO NUCLEAR INSTRUMENT, INC
9102-EZ-17-S
In Commercial Distribution

  • 00817330025258 ()
9102-EZ-17-S

  • General-purpose brachytherapy system applicator, manual
No Description
MICK RADIO NUCLEAR INSTRUMENT, INC
9102-EZ-15-S
In Commercial Distribution

  • 00817330025210 ()
9102-EZ-15-S

  • General-purpose brachytherapy system applicator, manual
No Description
MICK RADIO NUCLEAR INSTRUMENT, INC
9102-EZ-14-S
In Commercial Distribution

  • 00817330025197 ()
9102-EZ-14-S

  • General-purpose brachytherapy system applicator, manual
No Description
MICK RADIO NUCLEAR INSTRUMENT, INC
9102-EZ-11-S
In Commercial Distribution

  • 00817330025135 ()
9102-EZ-11-S

  • General-purpose brachytherapy system applicator, manual
No Description
MICK RADIO NUCLEAR INSTRUMENT, INC
9102-EZ-10-S
In Commercial Distribution

  • 00817330025111 ()
9102-EZ-10-S

  • General-purpose brachytherapy system applicator, manual
No Description
MICK RADIO NUCLEAR INSTRUMENT, INC
9102-EZ-06-S
In Commercial Distribution

  • 00817330025036 ()
9102-EZ-06-S

  • General-purpose brachytherapy system applicator, manual
No Description
MICK RADIO NUCLEAR INSTRUMENT, INC
9102-EZ-05-S
In Commercial Distribution

  • 00817330025012 ()
9102-EZ-05-S

  • General-purpose brachytherapy system applicator, manual
Multi Level Black Belt Triple Blade Retractor, Left for Wide Blades
KOROS U.S.A., INC.
7325-54
In Commercial Distribution

  • 00840199513666 ()
  • 10840199513663 ()
7325-54

  • Self-retaining surgical retractor, reusable
Multi Level Black Belt Triple Blade Retractor, Right for Wide Blades
KOROS U.S.A., INC.
7325-53
In Commercial Distribution

  • 00840199513659 ()
  • 10840199513656 ()
7325-53

  • Self-retaining surgical retractor, reusable
BEQ-HMOD 30000-USA Pediatric Quadrox iD, Softshell Venous Reser. 800ml, Better Bladder 1/4, CDI Sat Cell 1/4" System 100, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter
DATASCOPE CORP.
BEQ-TOP 25503
In Commercial Distribution

  • 00607567212039 ()
709000473

  • Cardiopulmonary bypass system blood tubing set
Audio Processor Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52612
In Commercial Distribution

  • 09008737526122 ()


  • Bone-conduction hearing implant system sound processor/vibrator
Audio Processor Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52611
In Commercial Distribution

  • 09008737526115 ()


  • Bone-conduction hearing implant system sound processor/vibrator
Audio Processor
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52527
In Commercial Distribution

  • 09008737525279 ()


  • Bone-conduction hearing implant system sound processor/vibrator
Audio Processor
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52526
In Commercial Distribution

  • 09008737525262 ()


  • Bone-conduction hearing implant system sound processor/vibrator
Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
34525-32
In Commercial Distribution

  • 10810929040912 ()
  • 00810929040915 ()


  • Medical device cleaning agent
No Description
Microgenics Corporation
963601
In Commercial Distribution

  • 00884883005921 ()


  • Hepatitis C virus antibody/antigen IVD, control
No Description
Microgenics Corporation
960600
Not in Commercial Distribution

  • 00884883005907 ()


  • West Nile virus nucleic acid IVD, control
No Description
Microgenics Corporation
963603
In Commercial Distribution

  • 00884883006027 ()


  • Hepatitis B virus antigen/antibody marker IVD, control
No Description
Microgenics Corporation
963602
In Commercial Distribution

  • 00884883005891 ()


  • HIV1 nucleic acid IVD, control
ETHOS PRO SMALL JOINT ANCHOR, PEEK, 3.3mm x 10mm, (2) #3-0 SUTURE W/(4) BB NEEDLE, 5/PK
HNM STAINLESS, LLC.
HNM-33-151458/PK
In Commercial Distribution

  • 00842962104071 ()
  • 00842962101865 ()
HNM-33-151458/PK

  • Tendon/ligament bone anchor, non-bioabsorbable
ETHOS PRO SMALL JOINT ANCHOR, PEEK, 3.3mm x 6mm, (2) #3-0 SUTURE W/(4) BB NEEDLE, 5/PK
HNM STAINLESS, LLC.
HNM-33-151457/PK
In Commercial Distribution

  • 00842962104064 ()
  • 00842962101858 ()
HNM-33-151457/PK

  • Tendon/ligament bone anchor, non-bioabsorbable
ETHOS PRO SMALL JOINT ANCHOR, PEEK, 2.9mm x 10mm, (2) #3-0 SUTURE W/(4) BB NEEDLE, 5/PK
HNM STAINLESS, LLC.
HNM-33-151456/PK
In Commercial Distribution

  • 00842962104057 ()
  • 00842962101841 ()
HNM-33-151456/PK

  • Tendon/ligament bone anchor, non-bioabsorbable
ETHOS PRO SMALL JOINT ANCHOR, PEEK, 2.9mm x 6mm, (2) #3-0 SUTURE W/(4) BB NEEDLE, 5/PK
HNM STAINLESS, LLC.
HNM-33-151455/PK
In Commercial Distribution

  • 00842962104040 ()
  • 00842962101834 ()
HNM-33-151455/PK

  • Tendon/ligament bone anchor, non-bioabsorbable
ETHOS PRO SMALL JOINT ANCHOR, TITANIUM, 3.3mm x 10mm, (2) #3-0 SUTURE W/(4) BB NEEDLE, 5/PK
HNM STAINLESS, LLC.
HNM-33-151478/PK
In Commercial Distribution

  • 00842962104279 ()
HNM-33-151478/PK

  • Self-retaining surgical retractor, reusable
ETHOS PRO SMALL JOINT ANCHOR, TITANIUM, 3.3mm x 6mm, (2) #3-0 SUTURE W/(4) BB NEEDLE, 5/PK
HNM STAINLESS, LLC.
HNM-33-151477/PK
In Commercial Distribution

  • 00842962104262 ()
HNM-33-151477/PK

  • Self-retaining surgical retractor, reusable
ETHOS PRO SMALL JOINT ANCHOR, TITANIUM, 2.9mm x 10mm, (2) #3-0 SUTURE W/(4) BB NEEDLE, 5/PK
HNM STAINLESS, LLC.
HNM-33-151476/PK
In Commercial Distribution

  • 00842962104255 ()
HNM-33-151476/PK

  • Self-retaining surgical retractor, reusable
ETHOS PRO SMALL JOINT ANCHOR, TITANIUM, 2.9mm x 6mm, (2) #3-0 SUTURE W/(4) BB NEEDLE, 5/PK
HNM STAINLESS, LLC.
HNM-33-151475/PK
In Commercial Distribution

  • 00842962104248 ()
HNM-33-151475/PK

  • Self-retaining surgical retractor, reusable
BB marker, plastic, for Tomo/3D/CT, nipples and general marking, 2.0mm diameter,100/box https://xactmarkers.com/product/2-0mm-tomosynthesisct-bb-markers/
Solstice Corporation
M20SC
In Commercial Distribution

  • 10854623006102 ()
  • 00854623006105 ()
M20SC

  • Radiographic image marker, manual
  • Imaging lesion localization marker, external, single-use
BB marker, plastic, for Tomo/3D/CT, nipples and general marking, 1.5mm diameter,100/box https://xactmarkers.com/product/1-5mm-tomosynthesisct-bb-markers/
Solstice Corporation
M15SC
In Commercial Distribution

  • 10854623006096 ()
  • 00854623006099 ()
M15SC

  • Radiographic image marker, manual
  • Imaging lesion localization marker, external, single-use
BB marker, plastic, for Tomo/3D/CT, nipples and general marking, 2.3mm diameter,85/box https://xactmarkers.com/product/bb-markers-for-ct-m23sc/
Solstice Corporation
M23SC
In Commercial Distribution

  • 10854623006027 ()
  • 00854623006020 ()
M23SC

  • Radiographic image marker, manual
  • Imaging lesion localization marker, external, single-use
Alternating Pressure, Low Air Loss, Battery Backup, Universal Mattress System, 36" x 84" x 8"~10".
KAP MEDICAL
Advanced Wave BB UMS
In Commercial Distribution

  • 00817012031096 ()
Advanced Wave BB UMS

  • Low-air-loss bed
Alternating Pressure, Low Air Loss, Battery Backup, Mattress System, 36" x 84" x 8".
KAP MEDICAL
Advanced Wave BB 84
In Commercial Distribution

  • 00817012031089 ()
Advanced Wave BB 84

  • Low-air-loss bed
Rotation, Low Air Loss, Battery Backup, Mattress System, 48 "x 80" x 10".
KAP MEDICAL
T-Wave BB MS 48
In Commercial Distribution

  • 00817012031065 ()
T-Wave BB MS 48

  • Low-air-loss bed
Rotation, Low Air Loss, Battery Backup, Mattress System, 36" x 84" x 10".
KAP MEDICAL
T-Wave BB MS 84
In Commercial Distribution

  • 00817012031058 ()
T-Wave BB MS 84

  • Low-air-loss bed
Alternating Pressure, Low Air Loss, Battery Backup, Width and Length Expansion, Mattress System, 36"~42"~48" x 80"~85"~90" x 10".
KAP MEDICAL
Advanced Wave BB XMS
In Commercial Distribution

  • 00817012031041 ()
Advanced Wave BB XMS

  • Low-air-loss bed
Alternating Pressure, On-Demand Low Air Loss, Battery Backup, Universal Mattress System, 36"x 86"x 9"
KAP MEDICAL
Comfort Wave BB UMS
In Commercial Distribution

  • 00817012031003 ()
Comfort Wave BB UMS

  • Low-air-loss bed
Pediatric, Pulsating, Battery Backup, Mattress System, 60"x30"x6".
KAP MEDICAL
Pediatric Wave BB MS
In Commercial Distribution

  • 00817012030730 ()
Pediatric Wave BB MS

  • Low-air-loss bed
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