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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6F INFINITI AMBI 125CM TG 4.5
Cordis US Corp.
555625T451
In Commercial Distribution

  • 20705032100165 ()
  • 10705032100168 ()
555625T451

  • Angiographic catheter, single-use
5F INFINITI AMBI 125CM TG 4.5
Cordis US Corp.
555525T451
In Commercial Distribution

  • 20705032100158 ()
  • 10705032100151 ()
555525T451

  • Angiographic catheter, single-use
6F INFINITI AMBI 100CM TG 4.5
Cordis US Corp.
555600T451
In Commercial Distribution

  • 20705032100141 ()
  • 10705032100144 ()
555600T451

  • Angiographic catheter, single-use
5F INFINITI AMBI 100CM TG 4.5
Cordis US Corp.
555500T451
In Commercial Distribution

  • 20705032100134 ()
  • 10705032100137 ()
555500T451

  • Angiographic catheter, single-use
6F INFINITI AMBI 125CM TG 4.0
Cordis US Corp.
555625T401
In Commercial Distribution

  • 20705032100127 ()
  • 10705032100120 ()
555625T401

  • Angiographic catheter, single-use
5F INFINITI AMBI 125CM TG 4.0
Cordis US Corp.
555525T401
In Commercial Distribution

  • 20705032100110 ()
  • 10705032100113 ()
555525T401

  • Angiographic catheter, single-use
6F INFINITI AMBI 100CM TG 4.0
Cordis US Corp.
555600T401
In Commercial Distribution

  • 20705032100103 ()
  • 10705032100106 ()
555600T401

  • Angiographic catheter, single-use
5F INFINITI AMBI 100CM TG 4.0
Cordis US Corp.
555500T401
In Commercial Distribution

  • 20705032100097 ()
  • 10705032100090 ()
555500T401

  • Angiographic catheter, single-use
TRUE MANAGER AIR APP - Apple iOS
TRIVIDIA HEALTH, INC.
TRUE MANAGER AIR APP - Apple iOS
In Commercial Distribution

  • 00021292013196 ()


  • Self-care monitoring/reporting software
ERGOPERIO KIRKLAND CHISEL S13K/TG 190MM
Aesculap AG
DB030R
In Commercial Distribution

  • 04046964540165 ()
DB030R

  • Bone-coring punch, reusable
OB Legacy System iOS Software System
Airstrip Technologies, Inc.
1001
In Commercial Distribution

  • B15310010 ()


  • Bedside monitor remote-viewing software, physiological parameter
SCS Remote App (compatible with iOS)
NALU MEDICAL, INC.
53002-002
In Commercial Distribution

  • 00812537033013 ()
53002-002

  • Implantable electrical stimulation device management software
Athena GTX Device Management Suite - iOS
ATHENA GTX, INC.
ADMS iOS Software
In Commercial Distribution

  • B3943950009000 ()
395-0009-00

  • Centralized patient monitor
SFTWR MMT-6102 AHCL APP 2.7 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000968175 ()


  • Self-care monitoring/reporting software
SFTWR MMT-6102 AHCL APP 2.2 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000867638 ()


  • Self-care monitoring/reporting software
ImmunoCAP Specific IgG, Antigen tg, Thyroglobulin
Phadia AB
14-4507-01
In Commercial Distribution

  • 07333066004006 ()
  • 07333066003993 ()
14-4507-01

  • Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)
XiVE® TG Castable Waxing Sleeve
Dentsply Implants Manufacturing GmbH
32254245
In Commercial Distribution

25-4245

  • Dental implant suprastructure kit
Vial Adapter 20mm Swabable TG- VF
WEST PHARMA. SERVICES IL, . LTD
8072022
In Commercial Distribution

  • 27290108240287 ()
  • 17290108240280 ()
  • 07290108240283 ()


  • Vial transfer spike
SFTWR MMT-6102 AHCL APP 2.6 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000943264 ()


  • Self-care monitoring/reporting software
SFTWR MMT-6102 AHCL APP 2.5 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000910150 ()


  • Self-care monitoring/reporting software
SFTWR MMT-6112 CP IOS V2.3.0 US
MEDTRONIC MINIMED, INC.
MMT-6112
In Commercial Distribution

  • 00763000437787 ()


  • Patient health record information system application software
SFTWR MMT-6112 CP IOS V2.2.0 OUS
MEDTRONIC MINIMED, INC.
MMT-6112
In Commercial Distribution

  • 00763000432645 ()


  • Patient health record information system application software
SFTWR MMT-6102 AHCL APP 1.3.3 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000416676 ()


  • Self-care monitoring/reporting software
SOFTWARE MMT-8060 INSULIN PEN IOS APP
MEDTRONIC MINIMED, INC.
MMT-8060
In Commercial Distribution

  • 00763000489953 ()


  • Empty self-injector, mechanical
Triglycerides Reagent (TG 2 x 300)
Beckman Coulter, Inc.
445850
In Commercial Distribution

  • 15099590233228 ()
445850

  • Triglyceride IVD, kit, spectrophotometry
Sftwr MMT-6102 AHCL 2.1.1 App iOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000827793 ()


  • Self-care monitoring/reporting software
Sftwr MMT-6112 CP iOS 3.3.1 US
MEDTRONIC MINIMED, INC.
MMT-6112
In Commercial Distribution

  • 00763000827304 ()


  • Patient health record information system application software
SFTWR CSS7200 GRDN IOS APP V3.2.1
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution

  • 00763000158392 ()


  • Patient health record information system application software
TG OSSEOTITE® 6/6MM PILOT DRILL
BIOMET 3I, LLC
PSD600
In Commercial Distribution

  • 00844868014553 ()


  • Fixture/appliance dental drill bit, reusable
TG OSSEOTITE® 5/6MM PILOT DRILL
BIOMET 3I, LLC
PSD500
In Commercial Distribution

  • 00844868014546 ()


  • Fixture/appliance dental drill bit, reusable
TG OSSEOTITE® 2/3MM PILOT DRILL
BIOMET 3I, LLC
PSD100
In Commercial Distribution

  • 00844868014539 ()


  • Fixture/appliance dental drill bit, reusable
No Description
Roche Diagnostics GmbH
08906556160
In Commercial Distribution

  • 07613336203569 ()
08906556160

  • Thyroglobulin IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08991405190
In Commercial Distribution

  • 07613336171394 ()
08991405190

  • Thyroglobulin IVD, calibrator
No Description
Roche Diagnostics GmbH
08906564190
In Commercial Distribution

  • 07613336169582 ()
08906564190

  • Thyroglobulin IVD, kit, chemiluminescent immunoassay
RepairSet
Dentsply Implants Manufacturing GmbH
25-5020
In Commercial Distribution

  • 07392532223327 ()
25-5020

  • Dental/maxillofacial surgical procedure kit, non-medicated, single-use
Implant Analog/Soldering Analog D3.4-4.5
Dentsply Implants Manufacturing GmbH
25-4010
In Commercial Distribution

  • 07392532223150 ()
25-4010

  • Dental implant suprastructure, temporary, preformed, single-use
PickUp Impression Coping with Guide Pin (single-tooth/bridge) D3.4-4.5
Dentsply Implants Manufacturing GmbH
25-1805
In Commercial Distribution

  • 07392532223143 ()
25-1805

  • Dental implant suprastructure, temporary, preformed, single-use
Guide Pin for PickUp Impression Coping
Dentsply Implants Manufacturing GmbH
25-1701
In Commercial Distribution

  • 07392532223136 ()
25-1701

  • Dental implant suprastructure, temporary, preformed, single-use
Transfer Impression Coping short
Dentsply Implants Manufacturing GmbH
25-1605
Not in Commercial Distribution

  • 07392532223129 ()
25-1605

  • Dental implant suprastructure, temporary, preformed, single-use
Transfer Impression Coping
Dentsply Implants Manufacturing GmbH
25-1600
Not in Commercial Distribution

  • 07392532223112 ()
25-1600

  • Dental implant suprastructure, temporary, preformed, single-use
Kosmos Application loaded on an iPad.
ECHONOUS, INC.
iOS 4.X
Not in Commercial Distribution

  • 09353278000823 ()


  • Ultrasound imaging system application software
KOSMOS OTS iOS SOFTWARE PACKAGE [2.X]
ECHONOUS, INC.
P007944
In Commercial Distribution

  • 09353278000762 ()


  • Ultrasound imaging system application software
Stand alone software used to collect, store and print patient data on various iOS devices
Zoll Medical Corporation
ZEPCRU
In Commercial Distribution

  • 00847946021924 ()


  • Medical equipment clinical data interfacing software
MINI ACCESS KIT 5FR/NT/TG GDWR
MEDLINE INDUSTRIES, INC.
DYNJMAST18
In Commercial Distribution

  • 10889942930944 ()
DYNJMAST18

  • General surgical procedure kit, non-medicated, single-use
MINI ACCESS KIT 5FR/NT/TG GDWR
MEDLINE INDUSTRIES, INC.
DYNJMAST16
In Commercial Distribution

  • 10889942930920 ()
DYNJMAST16

  • General surgical procedure kit, non-medicated, single-use
MINI ACCESS KIT 4FR/NT/TG GDWR
MEDLINE INDUSTRIES, INC.
DYNJMAST14
In Commercial Distribution

  • 10889942930548 ()
DYNJMAST14

  • General surgical procedure kit, non-medicated, single-use
MINI ACCESS KIT 4FR/NT/TG GDWR
MEDLINE INDUSTRIES, INC.
DYNJMAST12
In Commercial Distribution

  • 10889942930524 ()
DYNJMAST12

  • General surgical procedure kit, non-medicated, single-use
SURGICAL CHISELS 13K/TG 3.5 / 3 mm
Power Dental U.S.A. Inc.
2001
In Commercial Distribution

  • D94320010 ()
2001

  • Dressing/utility forceps, scissors-like, reusable
  • Periodontal hoe
Mobile application compatible to iOS operating system
ST. JUDE MEDICAL, INC.
APP1005
In Commercial Distribution

  • 05415067032829 ()
APP1005

  • Implantable cardiac device management application software
S13K/TG COMB. 6 MM #6 Handle
HU-FRIEDY MFG. CO., LLC
PJO/36
In Commercial Distribution

  • 10889950018955 ()
PJO/36

  • Periodontal file/rasp, manual
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