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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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CONNECTOR MS026 PARALLEL CLOSED DOMINO
MEDICREA INTERNATIONAL
MS026
In Commercial Distribution

  • 03613720295754 ()


  • Bone-screw internal spinal fixation system connector
No Description
CEDIC SRL
F00128
In Commercial Distribution

  • 08056093720075 ()
  • 08056093720068 ()
  • 08056093720051 ()


  • Enteral feeding/medication connector, non-sterile
CONNECTOR MS025 PARALLEL OPEN/CLOSED DOM
MEDICREA INTERNATIONAL
MS025
In Commercial Distribution

  • 03613720293545 ()


  • Bone-screw internal spinal fixation system connector
No Description
ACCUTRON, INC.
35500
In Commercial Distribution

  • 00813830023954 ()
35500

  • Anaesthesia face mask, reusable
No Description
ACCUTRON, INC.
27542
In Commercial Distribution

  • 00813830023749 ()
27542

  • Oxygen/air/nitrous oxide breathing gas mixer
No Description
ACCUTRON, INC.
27518
In Commercial Distribution

  • 00813830023695 ()
27518

  • Oxygen/air/nitrous oxide breathing gas mixer
Connect instrument to tubing (such as bi-manual I/A tubing).
HURRICANE MEDICAL INC
9303
In Commercial Distribution

  • 10813465012146 ()
  • 00813465012149 ()

  • Length: 29 Millimeter
9303

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
CABLE V1-MPC TO PADTAC/WHITE
Tz Medical, Inc.
PAD 6092
In Commercial Distribution

  • 00811331018356 ()


  • Electrical catheter connection cable/switch
Goat antiserum to Antithrombin III
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761480 ()
148002

  • Antithrombin III (ATIII) IVD, kit, precipitation/immunodiffusion
goat antiserum to Human Alpha 1 Antitrypsin
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761220 ()
122002

  • Alpha-1-antitrypsin (protease inhibitor) IVD, reagent
Goat Antiserum to Human C-3 (b1c only)
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761190 ()
119002

  • Complement components C3/C3c IVD, antibody
Goat antiserum to Human C-4 (b1e)
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761090 ()
109002

  • Complement components C4/C4c IVD, antibody
Goat antiserum to Whole Human Serum
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761000 ()
100002

  • Plasma protein IVD, control
No Description
ACCUTRON, INC.
28559-FRU
In Commercial Distribution

  • 00813830027327 ()
28559-FRU

  • Anaesthesia workstation gas scavenger
The Calypso breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for single users. Package special edition for tenders only.
Ardo medical AG
63.00.330T
In Commercial Distribution

  • 00814079022166 ()
63.00.330T

  • Breast pump, electric
LEAD WIRE, PINCH TO 2000
CURBELL MEDICAL PRODUCTS, INC.
DLW-05BK-40AS-0000
In Commercial Distribution

  • 90840828100321 ()
  • 90840828100314 ()
  • 90840828100338 ()
6765

  • Electrocardiographic electrode, single-use
0.018" (0.47MM) X 45CM STAINLESS STEEL GUIDEWIRE
JET MEDICAL, INC.
JT140184501
Not in Commercial Distribution

  • 50810988021271 ()
  • 00810988021276 ()


  • Peripheral vascular guidewire, manual
0.018" (0.47MM) X 45CM NITINOL GUIDEWIRE
JET MEDICAL, INC.
JT140184500
Not in Commercial Distribution

  • 50810988021264 ()
  • 00810988021269 ()


  • Peripheral vascular guidewire, manual
No Description
LUMENIS LTD.
Vanilla to OptiLight Upgrade Kit
In Commercial Distribution

  • 07290109145266 ()


  • Intense pulsed light dry eye therapy unit
This device is intended for use during cardiopulmonary bypass in conjunction with other medically approved devices and equipment that are utilized for this procedure.
Cardiomed Supplies Inc
1.3
In Commercial Distribution

  • 16641670004700 ()
  • 36641670004711 ()
C-869

  • Low-pressure tubing connector, single-use, sterile
Dental glass ceramic material, colored to match the VITAPAN® color system. It is used for the ceramic coating of titanium and titanium alloys as well as zirconium dioxide-based frame materials.
Schütz Dental GmbH
624754
In Commercial Distribution

  • ESDG6247541 ()


  • Dental appliance fabrication material, ceramic
Module
NOVASTEP
ACC1005P0005
In Commercial Distribution

  • 03700879503486 ()
ACC1005P0005

  • Device sterilization/disinfection container, reusable
The reference cable is connected to a common ECG-like electrode applied to the patient to acquire reference signal of electric impedance data. The accessory has been developed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized.
Timpel S/A
ACE-00034
In Commercial Distribution

  • 07898966433290 ()


  • Analytical non-scalp cutaneous lead
The reference cable is connected to a common ECG-like electrode applied to the patient to acquire reference signal of electric impedance data. The accessory has been developed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized.
Timpel S/A
DX-0TC03
In Commercial Distribution

  • 07898959841729 ()


  • Analytical non-scalp cutaneous lead
iOS
RESMED PTY LTD
22243
In Commercial Distribution

  • 00619498222438 ()


  • Ventilator application software
Libre IOS App US
ABBOTT DIABETES CARE INC
78746-01
In Commercial Distribution

  • 00357599841003 ()
78746-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
No Description
NXSTAGE MEDICAL, INC.
NX3094
Not in Commercial Distribution

  • 00842289101883 ()


  • Medical equipment clinical data interfacing software
Hearing device app
AMPLIFON SPA
5.0.2
In Commercial Distribution

  • 08059606110356 ()


  • Hearing aid/implant system remote control
QuicklyPro-APP is a medical software that supports healthcare professionals, in general the physiotherapist, in managing the rehabilitation plan; in detail, it allows the patient at home to view and perform the exercises assigned to him by the physiotherapist, at the end of the exercises the results obtained are recorded and sent to the QP-Rehab platform where the physiotherapist can consult them.
QUICKLYPRO SRL
1.1.2
In Commercial Distribution

  • 08056999860035 ()


  • Biomechanical function analysis/rehabilitation software
No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution

  • 00190198909541 ()


  • Cardiopulmonary physiological parameter analysis software, professional-only
No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution

  • 00190198909534 ()


  • Cardiopulmonary physiological parameter analysis software, professional-only
Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM mobile application, as accessory of the Subject device. It allows to monitor the user and guide rehabilitation and training through specific protocols.
NCS LAB SRL
SPM01A1
In Commercial Distribution

  • 08051122040926 ()
SPM01A1

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
BIOTRONIK SE & Co. KG
2.5
In Commercial Distribution

  • 04035479180461 ()
469464

  • Implantable cardiac device management application software
iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400063
In Commercial Distribution

  • J00714000630631 ()
1400063

  • Dental treatment application software
iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400051
In Commercial Distribution

  • J00714000510511 ()
1400051

  • Surgical power tool system control unit, line-powered
No Description
Nox Medical ehf.
NOX-NOXTURNAL_APP
Not in Commercial Distribution

  • 15694311110019 ()
536210

  • Sleep disorder interpretive software, professional-only
APP, Bluetooth, otoTune iOS for self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990019-SWH
In Commercial Distribution

  • 00850016231383 ()


  • Audiometric/hearing device software
No Description
Get-Grin Inc.
Initial Release
In Commercial Distribution

  • D962GGA00001 ()


  • Radiological PACS software
Clue is a digital smartphone application helping people with cycles better understand their menstrual and reproductive health. There are three different modes for users to pick from, depending on what suits their current goal best Clue Period Tracking, Clue Conceive, and Clue Pregnancy. Across all modes there are different features that allow users to track their health experiences, access current scientific literature, and learn more about what’s happening to their body. Both a free version and a paid premium version of the app, called Clue Plus, are available to users. Clue Conceive is a mode of the Clue app. Clue Conceive's proprietary algorithm uses period start date information entered by the user to provide predictions on the best days to try and conceive.
BioWink GmbH
iOS
In Commercial Distribution

  • 04260749840039 ()


  • Self-care monitoring/reporting software
ECG lead adapter/SIEMENS & DRAEGER Yoke to XY type 5 lead/common European and American standard (33525)
Unimed Medical Supplies, Inc.
115020065
In Commercial Distribution

  • 06945664899338 ()


  • Electrocardiographic lead set, reusable
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