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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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IV START KIT W/ CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYNDV2571
In Commercial Distribution

  • 00653160357561 ()
  • 10653160357568 ()
DYNDV2571

  • Peripheral intravenous catheterization support kit
IV START KIT W/ CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYNDV2571A
In Commercial Distribution

  • 00653160373646 ()
  • 10653160373643 ()
DYNDV2571A

  • Peripheral intravenous catheterization support kit
9340 2W INFBAL VLV MRI APP
HANS RUDOLPH, INC.
9340
Not in Commercial Distribution

  • 00817136024448 ()
CR1819

  • Pulmonary function valve
LUX-Dx Clinic Assistant app (Mobile application)
BOSTON SCIENTIFIC CORPORATION
622935-100
In Commercial Distribution

  • 00802526607615 ()
622935-100

  • Implantable cardiac device management application software
IMAGE SUITE / V4 SW MEDICAL APP
CARESTREAM HEALTH, INC.
CARESTREAM Image Suite
In Commercial Distribution

  • 60889971055989 ()
1055987

  • Radiological PACS software
SCS Remote App (compatible with iOS)
NALU MEDICAL, INC.
53002-002
In Commercial Distribution

  • 00812537033013 ()
53002-002

  • Implantable electrical stimulation device management software
LAMP Words For Life (US) App
PRENTKE ROMICH COMPANY
LAMP WFL App
In Commercial Distribution

  • 00816486021084 ()
16659

  • Voice synthesizer/digitizer
LAMP Words For Life (UK) App
PRENTKE ROMICH COMPANY
LAMP WFL (UK) App
In Commercial Distribution

  • 00816486021077 ()
16659-2

  • Voice synthesizer/digitizer
18X24CM DRCTVIEW HR SP APP SCRN
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with HR Screen
In Commercial Distribution

  • 60889971044617 ()
  • 40889971044613 ()
1044619

  • Digital imaging cassette/phosphor plate
Omnipod Display is secondary display app
Insulet Corporation
1.3.1
In Commercial Distribution

  • 10385081120265 ()
18239

  • Ambulatory insulin infusion pump software, data-display
Ascend Select Gantry common top asm with UDI
GE HEALTHCARE JAPAN CORPORATION
Ascend Select
In Commercial Distribution

  • 00195278718204 ()
RevolutionAscendSelect

  • Full-body CT system
Ascend Plus Gantry common top asm with UDI
GE HEALTHCARE JAPAN CORPORATION
Ascend Plus
In Commercial Distribution

  • 00195278718136 ()
RevolutionAscendPlus

  • Full-body CT system
Ascend Elite Gantry common top asm with UDI
GE HEALTHCARE JAPAN CORPORATION
Ascend Elite
In Commercial Distribution

  • 00195278718129 ()
RevolutionAscendElite

  • Full-body CT system
Common Ø6.5/ C=0.8/ P=5/ Wide/ Octa
Megagen Implant Co. Ltd
AOCEPW6515
In Commercial Distribution

  • 08806388208401 ()
AOCEPW6515T

  • Dental implant suprastructure, permanent, preformed
Common Ø5/ C=0.8/ P=5/ Small/ Octa
Megagen Implant Co. Ltd
AOCEPS5015
In Commercial Distribution

  • 08806388208395 ()
AOCEPS5015T

  • Dental implant suprastructure, permanent, preformed
Common Ø5.5/ C=0.8/ P=5/ Regular/ Octa
Megagen Implant Co. Ltd
AOCEPR5515
In Commercial Distribution

  • 08806388208388 ()
AOCEPR5515T

  • Dental implant suprastructure, permanent, preformed
Common Ø6.5/ C=0.8/ P=5/ Wide/ Non-octa
Megagen Implant Co. Ltd
ANOEPW6515
In Commercial Distribution

  • 08806388208333 ()
ANOEPW6515T

  • Dental implant suprastructure, permanent, preformed
Common Ø5/ C=0.8/ P=5/ Small/ Non-octa
Megagen Implant Co. Ltd
ANOEPS5015
In Commercial Distribution

  • 08806388208326 ()
ANOEPS5015T

  • Dental implant suprastructure, permanent, preformed
Common Ø5.5/ C=0.8/ P=5/ Regular/ Non-octa
Megagen Implant Co. Ltd
ANOEPR5515
In Commercial Distribution

  • 08806388208319 ()
ANOEPR5515T

  • Dental implant suprastructure, permanent, preformed
Common Ø6.5/ C=0.8/ P=5/ Wide/ Non-Octa
Megagen Implant Co. Ltd
ANOEPW6515
In Commercial Distribution

  • 08806388245024 ()
ANOEPW6515.MTN

  • Dental implant suprastructure, permanent, preformed
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