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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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XRpad Digital X-Ray Detector System - 00812589020160

3m cable to connect PerkinElmer XRpad Detector to XRpad IPU (Interface Power Unit)
PerkinElmer Technologies GmbH & Co. KG
XRpad LPT Detector Cable 10FT-3M
In Commercial Distribution

  • 00812589020160 ()

  • Length: 3 Meter
95510931H

  • Flat panel x-ray detector integration unit

XRpad Digital X-Ray Detector System - 00812589020153

Medical grade power supply with interfaces to integrate a PerkinElmer XRpad detector into an X-ray system
PerkinElmer Technologies GmbH & Co. KG
XRpad IPU
In Commercial Distribution

  • 00812589020153 ()

  • Width: 311 Millimeter
  • Length: 230 Millimeter
  • Height: 60 Millimeter
95510922H

  • Flat panel x-ray detector integration unit

XRpad Digital X-Ray Detector System - 00812589020122

Rechargeable Lithium-Ion Battery for use with PerkinElmer XRpad Detectors and Chargers Only
PerkinElmer Technologies GmbH & Co. KG
XRpad LBP
In Commercial Distribution

  • 00812589020122 ()

  • Weight: 0.4 Kilogram
  • Width: 211.2 Millimeter
  • Length: 238.5 Millimeter
  • Height: 6.3 Millimeter
95510920H-01

  • Flat panel x-ray detector integration unit

XRpad Digital X-Ray Detector System - 00812589020108

XRpad2 3025 is a lightweight wireless cassette detector with advanced features enabling digital radiography as never seen before. Featuring best-in-class 100 μm pixel size, direct deposition CsI scintillator and excellent DQE, XRpad2 3025 enables high resolution imaging with reduced X-ray exposure. Design of the second-generation XRpad is lightweight, robust and ergonomic, permitting easy lifting from table top. Automatic Exposure Detection, on-board corrections, and wireless access point mode make system integration quick and simple. New features of the XRpad2 3025 include fast preview, internal image storage, and magnetic connector for docking. Continuous imaging at up to 10 fps facilitates advanced applications such as tomosynthesis, dual energy subtraction, and image stitching.
Perkinelmer, Inc.
XRpad2 3025 HWC-M
In Commercial Distribution

  • 00812589020108 ()

  • Weight: 1.8 Kilogram
  • Width: 282 Millimeter
  • Length: 332 Millimeter
  • Depth: 15.5 Millimeter
95510991

  • Flat panel x-ray detector integration unit

XRpad Digital X-Ray Detector System - 00812589020085

The PerkinElmer XRpad 4343 F MED is a lightweight, cassette-sized flat panel detector for digital radiography. It fits into a conventional table or wall-stand bucky, just like a film-screen cassette. Featuring a 18.7 million pixel image matrix, a best-in-class 100 μm pixel pitch, and a direct deposited CsI scintillator, the PerkinElmer XRpad 4343 F MED provides exceptional image quality with a true 43 cm × 43 cm imaging area. A robust and lightweight aluminum frame with carbon-fiber entrance window allows for easier placement and cleaning. Automatic Exposure Detection simplifies integration.
Perkinelmer, Inc.
XRpad 4343 F MED
In Commercial Distribution

  • 00812589020085 ()

  • Weight: 4.1 Kilogram
  • Width: 460 Millimeter
  • Length: 460 Millimeter
  • Depth: 15 Millimeter
95510935-02

  • Flat panel x-ray detector integration unit

XRpad Digital X-Ray Detector System - 00812589020078

The PerkinElmer XRpad 4336 MED is a wireless, light weight, cassette-sized flat panel detector for digital radiography. It fits into a conventional table or wall-stand bucky, just like a film-screen cassette. Featuring a 15 million pixel image matrix, a best-in-class 100 μm pixel pitch, and a directly deposited CsI scintillator, the PerkinElmer XRpad 4336 MED provides exceptional image quality. True 35 cm × 43 cm imaging area per the ISO 4090 cassette standard is provided, along with a removable, rechargeable battery. A robust and lightweight aluminum frame with carbon-fiber entrance window and back cover allow for easier placement and cleaning. Automatic Exposure Detection simplifies integration.
Perkinelmer, Inc.
XRpad 4336 MED
In Commercial Distribution

  • 00812589020078 ()

  • Weight: 3.8 Kilogram
  • Width: 384 Millimeter
  • Length: 460 Millimeter
  • Depth: 15 Millimeter
95510925-02

  • Flat panel x-ray detector integration unit

XRpad Digital X-Ray Detector System - 00812589020054

XRpad2 4336 is a lightweight wireless cassette detector with advanced features enabling digital radiography as never seen before. Featuring best-in-class 100 μm pixel size, direct deposition CsI scintillator and excellent DQE, XRpad2 4336 enables high resolution imaging with reduced X-ray exposure. Design of the second-generation XRpad is lightweight, robust and ergonomic, permitting easy lifting from table top. Automatic Exposure Detection, on-board corrections, and wireless access point mode make system integration quick and simple. New features of the XRpad2 4336 include fast preview, internal image storage, and magnetic connector for docking. Continuous imaging at up to 8 fps facilitates advanced applications such as tomosynthesis, dual energy subtraction, and image stitching.
PerkinElmer Technologies GmbH & Co. KG
XRpad2 4336 HWC-M
In Commercial Distribution

  • 00812589020054 ()

  • Depth: 15.5 Millimeter
  • Length: 460 Millimeter
  • Width: 384 Millimeter
  • Weight: 3.2 Kilogram
95510981

  • Flat panel x-ray detector integration unit

XRpad Digital X-Ray Detector System - 00812589020092

XRpad2 4336 is a lightweight wireless cassette detector with advanced features enabling digital radiography as never seen before. Featuring best-in-class 100 μm pixel size, direct deposition CsI scintillator and excellent DQE, XRpad2 4336 enables high resolution imaging with reduced X-ray exposure. Design of the second-generation XRpad is lightweight, robust and ergonomic, permitting easy lifting from table top. Automatic Exposure Detection, on-board corrections, and wireless access point mode make system integration quick and simple. New features of the XRpad2 4336 include fast preview, internal image storage, and magnetic connector for docking. Continuous imaging at up to 8 fps facilitates advanced applications such as tomosynthesis, dual energy subtraction, and image stitching.
Perkinelmer, Inc.
XRpad2 4336 HWC-M
In Commercial Distribution

  • 00812589020092 ()

  • Weight: 3.2 Kilogram
  • Width: 384 Millimeter
  • Length: 460 Millimeter
  • Depth: 15.5 Millimeter
95510981

  • Flat panel x-ray detector integration unit

XRpad Digital X-Ray Detector System - 00812589020061

XRpad2 3025 is a lightweight wireless cassette detector with advanced features enabling digital radiography as never seen before. Featuring best-in-class 100 μm pixel size, direct deposition CsI scintillator and excellent DQE, XRpad2 3025 enables high resolution imaging with reduced X-ray exposure. Design of the second-generation XRpad is lightweight, robust and ergonomic, permitting easy lifting from table top. Automatic Exposure Detection, on-board corrections, and wireless access point mode make system integration quick and simple. New features of the XRpad2 3025 include fast preview, internal image storage, and magnetic connector for docking. Continuous imaging at up to 10 fps facilitates advanced applications such as tomosynthesis, dual energy subtraction, and image stitching.
PerkinElmer Technologies GmbH & Co. KG
XRpad2 3025 HWC-M
In Commercial Distribution

  • 00812589020061 ()

  • Depth: 15.5 Millimeter
  • Length: 332 Millimeter
  • Width: 282 Millimeter
  • Weight: 1.8 Kilogram
95510991

  • Flat panel x-ray detector integration unit

XRpad Digital X-Ray Detector System - 00812589020139

Rechargeable Lithium-Ion Battery Charger for use with PerkinElmer XRpad Battery Only
Perkinelmer, Inc.
XRpad LBC
In Commercial Distribution

  • 00812589020139 ()

  • Weight: 1.1 Kilogram
  • Width: 259 Millimeter
  • Height: 113 Millimeter
  • Depth: 82 Millimeter
95510921H

  • Flat panel x-ray detector integration unit

REPROCESSING DATA CAPTURE UNIT - 04953170336935

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2022
Not in Commercial Distribution

  • 04953170336935 ()


  • Endoscope washer/disinfector data recorder

iTero Mobile Computing Unit - 00816063020844

Scanner computer unit
Align Technology, Inc.
211386
In Commercial Distribution

  • 00816063020844 ()


  • Dental milling system, CAD/CAM, chairside

AESCULAP - 04046955206858

SINGLE USE TEST CARD F/DUV 400
Aesculap AG
PV032SU
Not in Commercial Distribution

  • 04046955206858 ()
PV032SU

  • Surgical microscope filter

Panel PC - 05065012584516

Medical computer loaded with Quadsense software.
EVENTUM ORTHOPAEDICS LTD
PC001
In Commercial Distribution

  • 05065012584516 ()


  • Arthroplasty force sensor display unit

N/A - 00643169944268

COMPUTER 945NCCPUE4 LAPTOP
MEDTRONIC SOFAMOR DANEK, INC.
945NCCPUE4
In Commercial Distribution

  • 00643169944268 ()


  • Portable computer

N/A - 00643169438170

COMPUTER 945NCCPUE4 NOTEBOOK
MEDTRONIC SOFAMOR DANEK, INC.
945NCCPUE4
In Commercial Distribution

  • 00643169438170 ()


  • Portable computer

Iradimed - 00856038001201

MRI Monitor Remote Tablet
IRADIMED CORP.
3885T
In Commercial Distribution

  • 00856038001201 ()
3885T

  • Portable computer

superDimension - 10884521545588

Planning Station
Covidien LP
AED00172-30
In Commercial Distribution

  • 10884521545588 ()


  • Portable computer

superDimension - 10884521785861

superDimension Planning Station
Covidien LP
ILS-0726-PS
In Commercial Distribution

  • 10884521785861 ()


  • Portable computer

superDimension - 10884521582835

Planning Station
Covidien LP
AED00170-01
In Commercial Distribution

  • 10884521582835 ()


  • Portable computer

Empower - 04032767832866

Tuning Device
OTTO BOCK HEALTHCARE
560X11=V2
In Commercial Distribution

  • B155EM40 ()
  • 04032767832866 ()


  • Portable computer

ImmersiveTouch - B940IVZBKIT0

ImmersiveTouch4 is a hardware accessory to ImmersiveTouch simulator. It supports ImmersiveTouch simulator to function as pre-operative software for simulating and evaluating surgical treatment options.
IMMERSIVETOUCH, INC.
ImmersiveTouch4
In Commercial Distribution

  • B940IVZBKIT0 ()


  • Portable computer

superDimension - 10884521200364

iLogic inReach;Planning Laptop
Covidien LP
AED00147-20
In Commercial Distribution

  • 10884521200364 ()


  • Portable computer

AIM™ System - 00840094456099

No Description
Advanced Bionics, LLC
CI-6126
In Commercial Distribution



  • Portable computer

AIM™ System - 00840094456082

No Description
Advanced Bionics, LLC
CI-6126
In Commercial Distribution



  • Portable computer

AIM™ System - 00840094454668

No Description
Advanced Bionics, LLC
CI-6126
In Commercial Distribution



  • Portable computer

AIM™ System - 00840094454651

No Description
Advanced Bionics, LLC
CI-6126
In Commercial Distribution



  • Portable computer

Linkstation MINI Evaluation Kit - 00816818022635

LinkStation MINI Evaluation Kit with power cord for United States and Canada. Bluetooth only.
ORTHOSENSOR INC
Linkstation MINI Evaluation Kit
Not in Commercial Distribution

  • 00816818022635 ()
05000-500-B

  • Arthroplasty force sensor display unit

LinkStation MINI - 00816818022536

LinkStation MINI with United States and Canada power cord. Bluetooth only
ORTHOSENSOR INC
LinkStation MINI
Not in Commercial Distribution

  • 00816818022536 ()
05000-001-B

  • Arthroplasty force sensor display unit

LinkStation MINI Evaluation Kit - 00816818020563

LinkStation MINI Evaluation Kit with Continental Europe/ Korea power cord and additional label for Korea
ORTHOSENSOR INC
LinkStation MINI Evaluation Kit
Not in Commercial Distribution

  • 00816818020563 ()
05000-507

  • Arthroplasty force sensor display unit
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