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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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Nitrile Patient Examination Glove, Indigo, Large
PROTECT U GUARD, LLC
P10103
In Commercial Distribution

  • B086101031 ()
  • B086101030 ()

  • Large


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Patient Examination Glove, Indigo, Medium
PROTECT U GUARD, LLC
P10102
In Commercial Distribution

  • B086101021 ()
  • B086101020 ()

  • Medium


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
No Description
PROTECT U GUARD, LLC
P10043
In Commercial Distribution

  • B086100431 ()
  • B086100430 ()


  • Surgical/medical face mask, single-use
No Description
PROTECT U GUARD, LLC
P10041
In Commercial Distribution

  • B086100411 ()
  • B086100410 ()


  • Surgical/medical face mask, single-use
No Description
PROTECT U GUARD, LLC
P10032
In Commercial Distribution

  • B086100321 ()
  • B086100320 ()


  • Surgical/medical face mask, single-use
Protect U Guard Flexible Fabric Adhesive Bandages Round 2.5cm
PROTECT U GUARD, LLC
P19142
In Commercial Distribution

  • B086291422 ()
  • B086191421 ()
  • B086091420 ()

  • Circumference: 25 Millimeter


  • Adhesive bandage
Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - Black
GREAT INNOVATIONS, LLC
MH-906
In Commercial Distribution

  • 00180104000813 ()


  • Room humidifier
Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - White
GREAT INNOVATIONS, LLC
MH-906
In Commercial Distribution

  • 00180104000806 ()


  • Room humidifier
Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - Navy
GREAT INNOVATIONS, LLC
MH-906
In Commercial Distribution

  • 00180104000790 ()


  • Room humidifier
Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - Red
GREAT INNOVATIONS, LLC
MH-906
In Commercial Distribution

  • 00180104000783 ()


  • Room humidifier
HD Rapid Simplified / 07 150grhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Vertex-Dental B.V.
HDARSP0700150
Not in Commercial Distribution

  • 08719425505121 ()


  • Dental appliance fabrication material, resin
Smart Spirometer connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
MIR SPIROBANK SMART
In Commercial Distribution

  • 08052990321759 ()


  • Expiratory peak flow meter, digital
Smart Spirometer connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
mSpirometer
In Commercial Distribution

  • 08052990321636 ()


  • Expiratory peak flow meter, digital
Smart Spirometer connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
MIR SPIROBANK SMART
In Commercial Distribution

  • 08052990321124 ()
911105

  • Expiratory peak flow meter, digital
Hoen Nerve Hook Straight 22cmhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
KOROS U.S.A., INC.
7225-05
In Commercial Distribution

  • 00840199507528 ()
  • 10840199507525 ()

  • 9x12mm
7225-05

  • Soft-tissue surgical hook, reusable
GAS-ASSISTED SPRAY SET ENDOSCOPIC APP. 5MM 30 CM, 1:1 RATIO
Micromedics, Inc.
SA-3654
In Commercial Distribution

  • 10815634020075 ()
  • 00815634020078 ()
  • 20815634020072 ()


  • Open-surgery adhesive/sealant applicator, dual-channel
6mm Kerrison Rongeur, 350mm https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Osseus Fusion Systems, LLC
1760-7070
In Commercial Distribution

  • B06217607070 ()
1760-7070

  • Spinal rongeur
DRSHD 1080p System, Rev 7https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Nds Surgical Imaging LLC
DRSHD.7
Not in Commercial Distribution

  • 00817613020000 ()


  • Endoscopic video image processing unit
Gastric Bypass Pack _Sterile_3EA/CShttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
GRI Medical & Electronic Technology Co., Ltd.
LGH011
In Commercial Distribution

  • 26931918174539 ()
  • 16931918174532 ()


  • General surgical procedure kit, non-medicated, single-use
T U R PACK B
Cardinal Health 200, LLC
SBA30TRISD
In Commercial Distribution

  • 50888439593103 ()
  • 10888439593105 ()
SBA30TRISD

  • Urological surgical procedure kit, non-medicated, single-use
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