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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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Expedite and standardize the 'bubble test' for gastrojejunal anastomoses and sleeve gastrectomy.
TOOLS FOR SURGERY, LLC
ALT-BA
In Commercial Distribution

  • 00861838000378 ()

  • Length: 6.76 Inch
ALT-BA

  • Endoscope inflation bulb
LinkBio Instrument Trays (Mega C): Mega C Assembly Tools
Link Bio Corp
MCGAT
In Commercial Distribution

  • 00810022401583 ()


  • Instrument tray, reusable
Lock screw for direct MGUIDE insertion tools (pack 3)
MIS Implants Technologies Ltd.
CG-SCRW0
In Commercial Distribution

  • 07290109012070 ()
CG-SCRW0

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
ZAAG Reorder Kit for 4 Roots (Mini) (No Tools)
Zest Anchors, LLC
04030
In Commercial Distribution

  • 00840481109102 ()


  • Dental implant suprastructure, permanent, preformed
ZAAG Reorder Kit for 4 Roots (Standard) (No Tools)
Zest Anchors, LLC
04010
In Commercial Distribution

  • 00840481109089 ()


  • Dental implant suprastructure, permanent, preformed
Implants and delivery tools for hyoid and tongue suspension.
Siesta Medical
FG0002
In Commercial Distribution

  • 00862211000206 ()


  • Sleep apnoea tongue implant, non-bioabsorbable
Instrument, Wrench Converter for W&H Hex Tools, Ø7.0mm
SOUTHERN IMPLANTS (PTY) LTD
I-WI-CST
In Commercial Distribution

  • 06009544014867 ()


  • Surgical torque wrench adaptor
Instrument, Wrench Converter for W&H Hex Tools, Ø8.0mm
SOUTHERN IMPLANTS (PTY) LTD
I-WI-CNB
In Commercial Distribution

  • 06009544014843 ()


  • Surgical torque wrench adaptor
No Description
LUXOTTICA GROUP SPA
WAW000001
In Commercial Distribution

  • 08056262013229 ()


  • Air-conduction hearing aid, spectacle
GTIN for 17002-02, 1/EA
ICU MEDICAL FLEET SERVICES, LLC
17002-02
In Commercial Distribution

  • 00887709127241 ()


  • Medical equipment clinical data interfacing software
GTIN for 17005-02, 1/EA
ICU MEDICAL FLEET SERVICES, LLC
17005-02
In Commercial Distribution

  • 00887709127234 ()


  • Medical equipment clinical data interfacing software
GTIN for 17003-02, 1/EA
ICU MEDICAL FLEET SERVICES, LLC
17003-02
In Commercial Distribution

  • 00887709127227 ()


  • Infusion pump medication-dosage application software
Infusion Safety Management Software
ICU MEDICAL, INC.
2.1
In Commercial Distribution

  • 00887709122819 ()
17005-01

  • Medical equipment clinical data interfacing software
Infusion Safety Management Software
ICU MEDICAL, INC.
2.1
In Commercial Distribution

  • 00887709122802 ()
17003-01

  • Infusion pump medication-dosage application software
SENSOR
BECTON, DICKINSON AND COMPANY
516700
In Commercial Distribution

  • 00382905167003 ()
  • 50382905167008 ()
516700

  • Intravenous line sensor, anaesthesia injection
BASE
BECTON, DICKINSON AND COMPANY
516701
In Commercial Distribution

  • 60382905167012 ()
  • 50382905167015 ()
  • 00382905167010 ()
516701

  • Intravenous injection automated detection/documentation system processor/transmitter
Infusion Safety Management Software
BAXTER HEALTHCARE CORPORATION
1.9
In Commercial Distribution

  • 20085412676610 ()
DOSEIQW0001

  • Infusion pump medication-dosage application software
Palatal Expanders
Align Technology, Inc.
9031
In Commercial Distribution

  • 00816063021391 ()


  • Orthodontic palate expander/teeth aligner, self-removable
Palatal Holder
Align Technology, Inc.
9032
In Commercial Distribution

  • 00816063021384 ()


  • Orthodontic retainer
TouchChat HD w/ WordPower App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021015 ()
18626

  • Voice synthesizer/digitizer
Infusion Management System (IMS)
Fresenius Kabi AG
030-0027-05
Not in Commercial Distribution

  • 00811050530399 ()
IMS

  • Infusion pump medication-dosage application software
ABBOTT PRISM Director Version 2.1
ABBOTT LABORATORIES
3R97-02
Not in Commercial Distribution

  • 00380740138400 ()
03R9702

  • Laboratory instrument/analyser application software IVD
ABBOTT PRISM Director Version 2.0
ABBOTT LABORATORIES
3R97-01
Not in Commercial Distribution

  • 00380740138394 ()
03R9701

  • Laboratory instrument/analyser application software IVD
Hearing Aid Feature watchOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195950095074 ()


  • Air-conduction hearing aid, in-the-ear
Hearing Aid Feature macOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195950095067 ()


  • Air-conduction hearing aid, in-the-ear
Hearing Aid Feature AirPods Pro 2 Firmware (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949149931 ()


  • Air-conduction hearing aid, in-the-ear
Hearing Aid Feature iOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949149924 ()


  • Air-conduction hearing aid, in-the-ear
Electrode Clip, Limb
NIHON KOHDEN AMERICA, INC.
NC-143E
In Commercial Distribution

  • 10841983103084 ()
  • 00841983103087 ()
NC-143E

  • Electrocardiograph, professional, multichannel
Infusion Safety Management Software
BAXTER HEALTHCARE CORPORATION
1.8
In Commercial Distribution

  • 10085412676613 ()
DOSEIQW0001

  • Infusion pump medication-dosage application software
Electrode Clip, Limb, 4/BX
NIHON KOHDEN CORPORATION
NC-143E
In Commercial Distribution

  • 04931921871355 ()
NC-143E

  • Electrocardiograph, professional, multichannel
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