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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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AMSCO - 00724995151676

The AMSCO 400 Series Prevacuum Steam Sterilizers are designed for sterilization of materials used in healthcare facilities. The AMSCO 400 Series Prevacuum Steam Sterilizers are equipped with Prevacuum, gravity, leak test, and daily air removal test cycles and offers optional Steam Flush Pressure Pulse (SFPP) configuration.
Steris Mexico, S. de R.L. de C.V.
36SL
In Commercial Distribution

  • 00724995151676 ()
SR21

  • Steam sterilizer

AMSCO - 00724995151652

The AMSCO 400 Series Prevacuum Steam Sterilizers are designed for sterilization of materials used in healthcare facilities. The AMSCO 400 Series Prevacuum Steam Sterilizers are equipped with Prevacuum, gravity, leak test, and daily air removal test cycles and offers optional Steam Flush Pressure Pulse (SFPP) configuration.
Steris Mexico, S. de R.L. de C.V.
20
In Commercial Distribution

  • 00724995151652 ()
SR02

  • Steam sterilizer

Amsco Evolution - 00724995151638

The Amsco Evolution - Medium Steam Sterilizer. Amsco Evolution SFPP Steam Sterilizers are configured for Prevacuum sterilization of heat and moisture-stable materials used in healthcare facilities. These units can be equipped with Prevacuum, Steam Flush Pressure Pulse (SFPP), gravity, liquid, and daily air removal test cycles.
Steris Mexico, S. de R.L. de C.V.
HC-900
In Commercial Distribution

  • 00724995151638 ()
UE01

  • Steam sterilizer

Amsco Evolution - 00724995151614

The Amsco Evolution - Medium Steam Sterilizer. Amsco Evolution SFPP Steam Sterilizers are configured for Prevacuum sterilization of heat and moisture-stable materials used in healthcare facilities. These units can be equipped with Prevacuum, Steam Flush Pressure Pulse (SFPP), gravity, liquid, and daily air removal test cycles.
Steris Mexico, S. de R.L. de C.V.
HC-800
In Commercial Distribution

  • 00724995151614 ()
UE22

  • Steam sterilizer

Amsco Evolution - 00724995151591

The Amsco Evolution - Medium Steam Sterilizer. Amsco Evolution SFPP Steam Sterilizers are configured for Prevacuum sterilization of heat and moisture-stable materials used in healthcare facilities. These units can be equipped with Prevacuum, Steam Flush Pressure Pulse (SFPP), gravity, liquid, and daily air removal test cycles.
Steris Mexico, S. de R.L. de C.V.
HC-600
In Commercial Distribution

  • 00724995151591 ()
UE21

  • Steam sterilizer

Amsco Evolution - 00724995151577

The Amsco Evolution Floorloader - Large. This Amsco Evolution SFPP Steam Sterilizer is configured for Prevacuum sterilization of heat and moisture-stable materials used in healthcare facilities. These units are equipped with Prevacuum, Steam Flush Pressure Pulse (SFPP), gravity, liquid, Dart (Bowie-Dick) and vacuum leak test cycles.
Steris Mexico, S. de R.L. de C.V.
HC-3000
In Commercial Distribution

  • 00724995151577 ()
UE42

  • Steam sterilizer

Amsco Evolution - 00724995151539

The Amsco Evolution - Medium Steam Sterilizer. Amsco Evolution SFPP Steam Sterilizers are configured for Prevacuum sterilization of heat and moisture-stable materials used in healthcare facilities. These units can be equipped with Prevacuum, Steam Flush Pressure Pulse (SFPP), gravity, liquid, and daily air removal test cycles.
Steris Mexico, S. de R.L. de C.V.
HC-1500
In Commercial Distribution

  • 00724995151539 ()
UE03

  • Steam sterilizer

Harmony - 00724995151461

Ceiling supported surgical lighting system consisting of one or more LED lightheads.
STERIS CORPORATION
LED Surgical Lighting System
Not in Commercial Distribution

  • 00724995151461 ()


  • Operating room light system
  • Operating room light
  • Medical monitor/light mount

HarmonyAIR - 00724995151454

The HarmonyAIR Surgical Lighting System G-Series is a variable pattern, variable intensity surgical lighting fixture designed to provide visible illumination of the surgical field or the patient for the operating room staff.
STERIS CORPORATION
G-Series Surgical Lighting System
In Commercial Distribution

  • 00724995151454 ()
LG

  • Medical monitor/light mount
  • Operating room light system
  • Operating room light

HarmonyAIR - 00724995151447

The HarmonyAIR Surgical Lighting System M-Series is a variable pattern, variable intensity surgical lighting fixture designed to provide visible illumination of the surgical field or the patient for the operating room staff.
STERIS CORPORATION
M-Series Surgical Lighting System
In Commercial Distribution

  • 00724995151447 ()
LM

  • Medical monitor/light mount
  • Operating room light system
  • Operating room light

NA - 00724995150839

The One Level General Purpose Vision Rack is designed to be used in the washer disinfector for the efficient cleaning, rinsing, drying and intermediate Level disinfection of two full size surgical instrument trays or miscellaneous hard goods.
Corporation Steris Canada
CM53
In Commercial Distribution

  • 00724995150839 ()
CM53

  • Sterilizer/disinfector rack

HarmonyAIR - 00724995150303

The HarmonyAIR Mobile Stand with G-Series Light Head is designed to provide a flexible, mobile lighting system for various surgical and diagnostic procedures in healthcare environments.
STERIS CORPORATION
G5 Mobile Surgical Light
Not in Commercial Distribution

  • 00724995150303 ()
LG0055

  • Transportable medical equipment stand, non-powered
  • Operating room light

HarmonyAIR - 00724995150297

The HarmonyAir Mobile Stand with M-Series Light Head is designed to provide a flexible, mobile lighting system for various surgical and diagnostic procedures in healthcare environments.
STERIS CORPORATION
M5 Mobile Surgical Light
Not in Commercial Distribution

  • 00724995150297 ()
LM0055

  • Operating room light
  • Transportable medical equipment stand, non-powered

VERIFY - 00724995023911

VERIFY Dual Temperature 28 well incubator allows incubation at two different temperatures in one incubator
STERIS CORPORATION
Incubator
In Commercial Distribution

  • 00724995023911 ()
S3080

  • Test tube heater

PROMUS Element™ Plus - 08714729807575

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911638300
Not in Commercial Distribution

  • 08714729807575 ()

  • 38 mm Stent Length
  • 3.00 mm Stent Diameter
H7493911638300

  • Coronary angioplasty balloon catheter, basic
  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated

PROMUS Element™ Plus - 08714729807568

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911632300
Not in Commercial Distribution

  • 08714729807568 ()

  • 32 mm Stent Length
  • 3.00 mm Stent Diameter
H7493911632300

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
  • Coronary angioplasty balloon catheter, basic

PROMUS Element™ Plus - 08714729807551

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911628300
Not in Commercial Distribution

  • 08714729807551 ()

  • 28 mm Stent Length
  • 3.00 mm Stent Diameter
H7493911628300

  • Coronary angioplasty balloon catheter, basic
  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated

PROMUS Element™ Plus - 08714729807544

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911624300
Not in Commercial Distribution

  • 08714729807544 ()

  • 24 mm Stent Length
  • 3.00 mm Stent Diameter
H7493911624300

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
  • Coronary angioplasty balloon catheter, basic

PROMUS Element™ Plus - 08714729807537

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911620300
Not in Commercial Distribution

  • 08714729807537 ()

  • 20 mm Stent Length
  • 3.00 mm Stent Diameter
H7493911620300

  • Coronary angioplasty balloon catheter, basic
  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated

PROMUS Element™ Plus - 08714729807520

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911616300
Not in Commercial Distribution

  • 08714729807520 ()

  • 3.00 mm Stent Diameter
  • 16 mm Stent Length
H7493911616300

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
  • Coronary angioplasty balloon catheter, basic

PROMUS Element™ Plus - 08714729807513

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911612300
Not in Commercial Distribution

  • 08714729807513 ()

  • 12 mm Stent Length
  • 3.00 mm Stent Diameter
H7493911612300

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
  • Coronary angioplasty balloon catheter, basic

PROMUS Element™ Plus - 08714729807506

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911608270
Not in Commercial Distribution

  • 08714729807506 ()

  • 2.75 mm Stent Diameter
  • 8 mm Stent Length
H7493911608270

  • Coronary angioplasty balloon catheter, basic
  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated

PROMUS Element™ Plus - 08714729807490

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911638270
Not in Commercial Distribution

  • 08714729807490 ()

  • 2.75 mm Stent Diameter
  • 38 mm Stent Length
H7493911638270

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
  • Coronary angioplasty balloon catheter, basic

PROMUS Element™ Plus - 08714729807483

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911632270
Not in Commercial Distribution

  • 08714729807483 ()

  • 32 mm Stent Length
  • 2.75 mm Stent Diameter
H7493911632270

  • Coronary angioplasty balloon catheter, basic
  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated

PROMUS Element™ Plus - 08714729807476

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911628270
Not in Commercial Distribution

  • 08714729807476 ()

  • 2.75 mm Stent Diameter
  • 28 mm Stent Length
H7493911628270

  • Coronary angioplasty balloon catheter, basic
  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated

PROMUS Element™ Plus - 08714729807469

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911624270
Not in Commercial Distribution

  • 08714729807469 ()

  • 2.75 mm Stent Diameter
  • 24 mm Stent Length
H7493911624270

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
  • Coronary angioplasty balloon catheter, basic

PROMUS Element™ Plus - 08714729807452

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911620270
Not in Commercial Distribution

  • 08714729807452 ()

  • 2.75 mm Stent Diameter
  • 20 mm Stent Length
H7493911620270

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
  • Coronary angioplasty balloon catheter, basic

PROMUS Element™ Plus - 08714729807445

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911616270
Not in Commercial Distribution

  • 08714729807445 ()

  • 16 mm Stent Length
  • 2.75 mm Stent Diameter
H7493911616270

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
  • Coronary angioplasty balloon catheter, basic

PROMUS Element™ Plus - 08714729807438

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911612270
Not in Commercial Distribution

  • 08714729807438 ()

  • 2.75 mm Stent Diameter
  • 12 mm Stent Length
H7493911612270

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
  • Coronary angioplasty balloon catheter, basic

PROMUS Element™ Plus - 08714729807421

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911608250
Not in Commercial Distribution

  • 08714729807421 ()

  • 2.50 mm Stent Diameter
  • 8 mm Stent Length
H7493911608250

  • Coronary angioplasty balloon catheter, basic
  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated

PROMUS Element™ Plus - 08714729807414

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911638250
Not in Commercial Distribution

  • 08714729807414 ()

  • 38 mm Stent Length
  • 2.50 mm Stent Diameter
H7493911638250

  • Coronary angioplasty balloon catheter, basic
  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated

PROMUS Element™ Plus - 08714729807407

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911632250
Not in Commercial Distribution

  • 08714729807407 ()

  • 2.50 mm Stent Diameter
  • 32 mm Stent Length
H7493911632250

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
  • Coronary angioplasty balloon catheter, basic

PROMUS Element™ Plus - 08714729807391

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911628250
Not in Commercial Distribution

  • 08714729807391 ()

  • 2.50 mm Stent Diameter
  • 28 mm Stent Length
H7493911628250

  • Coronary angioplasty balloon catheter, basic
  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated

PROMUS Element™ Plus - 08714729807384

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911624250
Not in Commercial Distribution

  • 08714729807384 ()

  • 24 mm Stent Length
  • 2.50 mm Stent Diameter
H7493911624250

  • Coronary angioplasty balloon catheter, basic
  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated

PROMUS Element™ Plus - 08714729807377

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911620250
Not in Commercial Distribution

  • 08714729807377 ()

  • 2.50 mm Stent Diameter
  • 20 mm Stent Length
H7493911620250

  • Coronary angioplasty balloon catheter, basic
  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated

PROMUS Element™ Plus - 08714729807360

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911616250
Not in Commercial Distribution

  • 08714729807360 ()

  • 16 mm Stent Length
  • 2.50 mm Stent Diameter
H7493911616250

  • Coronary angioplasty balloon catheter, basic
  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated

PROMUS Element™ Plus - 08714729807353

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911612250
Not in Commercial Distribution

  • 08714729807353 ()

  • 12 mm Stent Length
  • 2.50 mm Stent Diameter
H7493911612250

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
  • Coronary angioplasty balloon catheter, basic

PROMUS Element™ Plus - 08714729807346

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911608220
Not in Commercial Distribution

  • 08714729807346 ()

  • 2.25 mm Stent Diameter
  • 8 mm Stent Length
H7493911608220

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
  • Coronary angioplasty balloon catheter, basic

PROMUS Element™ Plus - 08714729807339

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911632220
Not in Commercial Distribution

  • 08714729807339 ()

  • 32 mm Stent Length
  • 2.25 mm Stent Diameter
H7493911632220

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
  • Coronary angioplasty balloon catheter, basic

PROMUS Element™ Plus - 08714729807322

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911628220
Not in Commercial Distribution

  • 08714729807322 ()

  • 28 mm Stent Length
  • 2.25 mm Stent Diameter
H7493911628220

  • Coronary angioplasty balloon catheter, basic
  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated

PROMUS Element™ Plus - 08714729807315

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911624220
Not in Commercial Distribution

  • 08714729807315 ()

  • 2.25 mm Stent Diameter
  • 24 mm Stent Length
H7493911624220

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
  • Coronary angioplasty balloon catheter, basic

PROMUS Element™ Plus - 08714729807308

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911620220
Not in Commercial Distribution

  • 08714729807308 ()

  • 2.25 mm Stent Diameter
  • 20 mm Stent Length
H7493911620220

  • Coronary angioplasty balloon catheter, basic
  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated

PROMUS Element™ Plus - 08714729807292

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911616220
Not in Commercial Distribution

  • 08714729807292 ()

  • 16 mm Stent Length
  • 2.25 mm Stent Diameter
H7493911616220

  • Coronary angioplasty balloon catheter, basic
  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated

PROMUS Element™ Plus - 08714729807285

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911612220
Not in Commercial Distribution

  • 08714729807285 ()

  • 12 mm Stent Length
  • 2.25 mm Stent Diameter
H7493911612220

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
  • Coronary angioplasty balloon catheter, basic

Bone Graft Container - 08057639712301

MCBio Bone Graft Container
MC BIO SRL
38570
In Commercial Distribution

  • 08057639712301 ()


  • Dental material mixing surface, chairside, reusable

Blade - Straight 2XL (9mm) - 08057639712295

Blade - Straight 2XL (9mm) Replace blade 2XL for Straight 2XL bone scraper of MCBio
MC BIO SRL
39340
In Commercial Distribution

  • 08057639712295 ()


  • Bone file/rasp, manual, reusable

Blade - Straight XL (8mm) - 08057639712288

Blade - Straight XL (8mm) Replace blade XL for Straight XL bone scraper of MCBio
MC BIO SRL
39770
In Commercial Distribution

  • 08057639712288 ()


  • Bone file/rasp, manual, reusable

Blade - Straight M (6mm) - 08057639712271

Blade - Straight M (6mm) Replace blade M for Straight M bone scraper of MCBio
MC BIO SRL
39810
In Commercial Distribution

  • 08057639712271 ()


  • Bone file/rasp, manual, reusable

Blade - Straight S (5mm) - 08057639712264

Blade - Straight S (5mm) Replace blade Sfor Straight S bone scraper of MCBio
MC BIO SRL
39760
In Commercial Distribution

  • 08057639712264 ()


  • Bone file/rasp, manual, reusable

Blade - Asym. 3XL (10mm) - 08057639712257

Blade - Asym. 3XL (10mm) Replace Asym. blade 3XL for Asym. 3XL bone scraper of MCBio
MC BIO SRL
38070
In Commercial Distribution

  • 08057639712257 ()


  • Bone file/rasp, manual, reusable
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