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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, White, Extra Large
PROTECT U GUARD, LLC
P10114
In Commercial Distribution

  • B086101141 ()
  • B086101140 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Patient Examination Glove, White, Large
PROTECT U GUARD, LLC
P10113
In Commercial Distribution

  • B086101131 ()
  • B086101130 ()

  • Large


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Patient Examination Glove, White, Medium
PROTECT U GUARD, LLC
P10112
In Commercial Distribution

  • B086101121 ()
  • B086101120 ()

  • Medium


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Patient Examination Glove, White, Small
PROTECT U GUARD, LLC
P10111
In Commercial Distribution

  • B086101111 ()
  • B086101110 ()

  • Small


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Patient Examination Glove, Indigo, Extra Large
PROTECT U GUARD, LLC
P10104
In Commercial Distribution

  • B086101041 ()
  • B086101040 ()

  • Extra Large


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
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
Nitrile Patient Examination Glove, Indigo, Small
PROTECT U GUARD, LLC
P10101
In Commercial Distribution

  • B086101011 ()
  • B086101010 ()

  • Small


  • 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
P10042
In Commercial Distribution

  • B086100421 ()
  • B086100420 ()


  • 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
P10033
In Commercial Distribution

  • B086100331 ()
  • B086100330 ()


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

  • B086100321 ()
  • B086100320 ()


  • Surgical/medical face mask, single-use
No Description
PROTECT U GUARD, LLC
P10031
In Commercial Distribution

  • B086100311 ()
  • B086100310 ()


  • 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
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
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
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
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
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
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
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
No Description
W.H. Holden, Inc.
10-5530
In Commercial Distribution

  • D9281055300 ()


  • Dental cheek retractor, professional, reusable
No Description
DIAGNOSTICA STAGO
00975
In Commercial Distribution

  • 03607450009750 ()
  • 13607450009757 ()


  • Buffered wash solution IVD
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