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
MERIDIAN MEDICAL SYSTEMS, LLC
RT 311
In Commercial Distribution

  • 00851354007142 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 310
In Commercial Distribution

  • 00851354007135 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 309
In Commercial Distribution

  • 00851354007128 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 308
In Commercial Distribution

  • 00851354007111 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 307
In Commercial Distribution

  • 00851354007104 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 306
In Commercial Distribution

  • 00851354007098 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 305
In Commercial Distribution

  • 00851354007081 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 304
In Commercial Distribution

  • 00851354007074 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 303
In Commercial Distribution

  • 00851354007067 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 302
In Commercial Distribution

  • 00851354007050 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 301
In Commercial Distribution

  • 00851354007043 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 204
In Commercial Distribution

  • 00851354007036 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 203
In Commercial Distribution

  • 00851354007029 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 202
In Commercial Distribution

  • 00851354007012 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 201
In Commercial Distribution

  • 00851354007005 ()


  • Flat panel x-ray detector integration unit
No Description
AGFA
5400/525
In Commercial Distribution

  • 05414904222225 ()

  • Width: 24 Centimeter
  • Length: 30 Centimeter
XBOQO

  • Flat panel x-ray detector integration unit
No Description
AGFA
5400/524
In Commercial Distribution

  • 05414904222218 ()

  • Length: 43 Centimeter
  • Width: 35 Centimeter
XBOPM

  • Flat panel x-ray detector integration unit
No Description
AGFA
5400/523
In Commercial Distribution

  • 05414904222201 ()

  • Width: 35 Centimeter
  • Length: 43 Centimeter
XBOOK

  • Flat panel x-ray detector integration unit
No Description
KONICA MINOLTA, INC.
AE81
In Commercial Distribution

  • 04560141950771 ()


  • Flat panel x-ray detector integration unit
6m cable to connect PerkinElmer XRpad Detector to XRpad IPU (Interface Power Unit)
PerkinElmer Technologies GmbH & Co. KG
XRpad LPT Detector Cable 20FT-6M
In Commercial Distribution

  • 00812589020214 ()

  • Length: 6 Meter
95510929H

  • Flat panel x-ray detector integration unit
20m Trigger Cable for use with PerkinElmer XRpad IPU
PerkinElmer Technologies GmbH & Co. KG
Trigger Cable, 65.5FT – 20M
In Commercial Distribution

  • 00812589020184 ()

  • Length: 20 Meter
95510257H

  • Flat panel x-ray detector integration unit
5m Trigger Cable for use with PerkinElmer XRpad IPU
PerkinElmer Technologies GmbH & Co. KG
Trigger Cable, 16.5FT – 5M
In Commercial Distribution

  • 00812589020177 ()

  • Length: 5 Meter
95510256H

  • Flat panel x-ray detector integration unit
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
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
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
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
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
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
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
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
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
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
IVD reagent kit containing 6 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0145
In Commercial Distribution

  • 00815381020185 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0144
In Commercial Distribution

  • 00815381020178 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Touch Panel
ST. JUDE MEDICAL, INC.
System
In Commercial Distribution

  • 05414734218436 ()
A21843

  • Image display unit, colour
Perception Panel
G&J Electronics Inc
PP-01
In Commercial Distribution

  • 00627843670919 ()


  • Gastrointestinal barostat
Hex Panel
Kinamed, Inc.
14-1P3-9020
In Commercial Distribution

  • 00898142001180 ()
14-1P3-9020

  • Cranioplasty sheet
Hex Panel
Kinamed, Inc.
14-1P3-9013
In Commercial Distribution

  • 00898142001159 ()
14-1P3-9013

  • Cranioplasty sheet
Gap Panel
Kinamed, Inc.
14-1P3-0886
In Commercial Distribution

  • 00898142001111 ()
14-1P3-0886

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
TCA PANEL
UTAK LABORATORIES, INC.
TCA U F NMS
In Commercial Distribution

  • B800TCAUFNMS5 ()
  • B800TCAUFNMS0 ()

  • Total Volume: 0.3 Milliliter
TCA U F NMS

  • Multiple-type clinical chemistry analyte profile IVD, control
MISCELLANEOUS PANEL
UTAK LABORATORIES, INC.
MP U F SCL
In Commercial Distribution

  • B800MPUFSCL5 ()
  • B800MPUFSCL0 ()

  • Total Volume: 5 Milliliter
MP U F SCL

  • Multiple therapeutic drugs/drugs of abuse IVD, control
MISCELLANEOUS PANEL
UTAK LABORATORIES, INC.
MP U F LSA
In Commercial Distribution

  • B800MPUFLSA5 ()
  • B800MPUFLSA0 ()

  • Total Volume: 10 Milliliter
MP U F LSA

  • Multiple therapeutic drugs/drugs of abuse IVD, control
Gap Panel
Kinamed, Inc.
16-1P3-1045
In Commercial Distribution

  • 00898142001685 ()
16-1P3-1045

  • Cranioplasty plate, alterable
pink panel
Shenzhen Jumper Medical Equipment Co.,Ltd.
JPD-500A
In Commercial Distribution

  • 06951740522229 ()


  • Pulse oximeter
OCS Wireless Monitor, Universal
TRANSMEDICS, INC.
2450
In Commercial Distribution

  • B00939301 ()
  • B00939270 ()

  • Height: 3.5 Inch
  • Width: 8.5 Inch
  • Length: 9.5 Inch
2450

  • Donor-organ preservation/transport system control unit
OCS Wireless Monitor, Heart
TRANSMEDICS, INC.
1410
In Commercial Distribution

  • B00913390 ()
  • B00926311 ()

  • Length: 9.5 Inch
  • Width: 8.5 Inch
  • Height: 3.5 Inch
1410

  • Donor-organ preservation/transport system control unit
RSLPP-OS (PREGNANCY PANEL, .5MM STARLITE, PREGNANCY PANEL, OS)
BURLINGTON MEDICAL, LLC
RSLPP-OS
In Commercial Distribution

  • 00840331274363 ()

  • XS Male


  • Radiation shielding apron
Medical computer loaded with Quadsense software.
EVENTUM ORTHOPAEDICS LTD
PC001
In Commercial Distribution

  • 05065012584516 ()


  • Arthroplasty force sensor display unit
Electro-Mesh Panel 4x8
PRIZM MEDICAL, INC.
EMSP48
In Commercial Distribution

  • B872EMSP480 ()


  • Transcutaneous electrical stimulation electrode, single-use
Electro-Mesh Panel 4x4
PRIZM MEDICAL, INC.
EMSP44
In Commercial Distribution

  • B872EMSP440 ()


  • Transcutaneous electrical stimulation electrode, single-use
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