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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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CardioSTAT - 17540279200072

CardioSTAT ECG Recorder 7D Test.
Icentia Inc.
10-006
In Commercial Distribution

  • 17540279200072 ()
  • 27540279200079 ()


  • Electrocardiographic ambulatory recorder

EART - 17540279105018

ECG Analysis and Reporting Tool.
Icentia Inc.
10-501
In Commercial Distribution

  • 17540279105018 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

SureForm - 00886874123652

45mm Curved Tip Stapler
INTUITIVE SURGICAL, INC.
436504
In Commercial Distribution

  • 10886874123659 ()
  • 00886874123652 ()

  • Length: 45 Millimeter
  • Outer Diameter: 14 Millimeter


  • Robotic surgical cutting stapler, single-use

SureForm - 00886874123645

45mm Straight Tip Stapler
INTUITIVE SURGICAL, INC.
436502
In Commercial Distribution

  • 10886874123642 ()
  • 00886874123645 ()

  • Length: 45 Millimeter
  • Outer Diameter: 14 Millimeter


  • Robotic surgical cutting stapler, single-use

Sureform - 00886874121931

8mm Stapler
INTUITIVE SURGICAL, INC.
48230M
In Commercial Distribution

  • 10886874121938 ()
  • 00886874121931 ()

  • Depth: 30 Millimeter


  • Surgical staple loading unit, non-cutting

Sureform - 00886874121924

8mm Stapler
INTUITIVE SURGICAL, INC.
48230W
In Commercial Distribution

  • 10886874121921 ()
  • 00886874121924 ()

  • Depth: 30 Millimeter


  • Surgical staple loading unit, non-cutting

Sureform - 00886874121917

8mm Stapler
INTUITIVE SURGICAL, INC.
48230B
In Commercial Distribution

  • 10886874121914 ()
  • 00886874121917 ()

  • Depth: 30 Millimeter


  • Surgical staple loading unit, non-cutting

SureForm - 00886874117590

SureForm 45 Curved-Tip
INTUITIVE SURGICAL, INC.
480545
In Commercial Distribution

  • 10886874117597 ()
  • 00886874117590 ()

  • Outer Diameter: 14 Millimeter


  • Robotic surgical cutting stapler, single-use

SureForm - 00886874117583

SureForm 45
INTUITIVE SURGICAL, INC.
480445
In Commercial Distribution

  • 10886874117580 ()
  • 00886874117583 ()

  • Outer Diameter: 14 Millimeter


  • Robotic surgical cutting stapler, single-use

SureForm - 00886874117125

SUREFORM 45 RELOAD WHITE
INTUITIVE SURGICAL, INC.
48345W
In Commercial Distribution

  • 10886874117122 ()
  • 00886874117125 ()

  • Depth: 2.5 Millimeter


  • Surgical staple loading unit, non-cutting

SureForm - 00886874117118

SUREFORM 45 RELOAD BLACK
INTUITIVE SURGICAL, INC.
48345T
In Commercial Distribution

  • 10886874117115 ()
  • 00886874117118 ()

  • Depth: 4.6 Millimeter


  • Surgical staple loading unit, non-cutting

SureForm - 00886874117101

SUREFORM 45 RELOAD GRAY
INTUITIVE SURGICAL, INC.
48345M
In Commercial Distribution

  • 10886874117108 ()
  • 00886874117101 ()

  • Depth: 2 Millimeter


  • Surgical staple loading unit, non-cutting

SureForm - 00886874117095

SUREFORM 45 RELOAD GREEN
INTUITIVE SURGICAL, INC.
48345G
In Commercial Distribution

  • 10886874117092 ()
  • 00886874117095 ()

  • Depth: 4.3 Millimeter


  • Surgical staple loading unit, non-cutting

SureForm - 00886874117088

SUREFORM 45 RELOAD BLUE
INTUITIVE SURGICAL, INC.
48345B
In Commercial Distribution

  • 10886874117085 ()
  • 00886874117088 ()

  • Depth: 3.5 Millimeter


  • Surgical staple loading unit, non-cutting

Sureform - 00886874121726

8mm Stapler
INTUITIVE SURGICAL, INC.
488530
In Commercial Distribution

  • 10886874121723 ()
  • 00886874121726 ()

  • Outer Diameter: 8 Millimeter
  • Length: 30 Millimeter


  • Robotic surgical cutting stapler, reusable

Straumann Computer Aided Restoration Service (C.A.R.E.S.) Ceramic Coping - 07630031728913

RN Screw for CARES® Abutment, ZrO2 , and instructions for use
Institut Straumann AG
Screws
In Commercial Distribution

  • 07630031728913 ()
048.788

  • Dental prosthesis/implant abutment screw

Straumann Computer Aided Restoration Service (C.A.R.E.S.) Ceramic Coping - 07630031717757

Custom Abutment Zirconia, for Straumann RN, incl. TAN screw
Institut Straumann AG
Final Abutments
In Commercial Distribution

  • 07630031717757 ()
040.688

  • Dental implant suprastructure, permanent, preformed

LEAF™ - 05000223499907

Capital equipment to support the Leaf sensor patient montitoring system
SMITH & NEPHEW MEDICAL LIMITED
66802119
In Commercial Distribution

  • 05000223499907 ()
66802119

  • Wireless patient monitor/sensor reporting software, professional-only

LEAF™ - 05000223499891

Capital equipment to support the Leaf sensor patient montitoring system
SMITH & NEPHEW MEDICAL LIMITED
66802118
In Commercial Distribution

  • 05000223499891 ()
66802118

  • Wireless patient monitor/sensor reporting software, professional-only

Atlas Sensor - 00860008806024

A reusable, wireless, Bluetooth device that sends patient body orientation and movement information to the Bedside Mobility Monitor (BMM) that is housed within the Atlas Wearable Patch.
Atlas Lift Tech, Inc.
Rev A
In Commercial Distribution

  • 00860008806024 ()


  • Wireless patient monitor/sensor reporting software, professional-only
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