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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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SleepmateUARS Disposable Sensors - 05707480041909

UARS Disposable Sensors, Sleepmate Min. purchase 10 pcs. = 1 pack Sleepmate no. 1601
Ambu A/S
816400-000/10
In Commercial Distribution

  • 05707480041909 ()
  • 05707480134014 ()
816400-000/10

  • Polysomnograph

Nellcor - 20884522042137

Adult SpO2 Sensor,Two Piece
Covidien LP
AI
Not in Commercial Distribution

  • 10884522042130 ()
  • 20884522042137 ()

  • Patient Weight, >30, KG;


  • Transcutaneous blood gas monitor sensor

ZEISS CONNECT - 04049539070135

The ZEISS® Connect App mobile application will be an optional accessory of ZEISS® UNO 3 microscope product. ZEISS® Connect application SW will be available to the end user as an iOS app and user should be able to download and install the same from Apple App store. ZEISS® Connect App will pair wirelessly to the UNO3 variants of microscope and associated peripheral devices (like monitor etc.). This database entry covers UDI for SW version 2.0 and higher. Version 2.0-> UDI - (01)04049539070135(10)200-> Version 3.0-> UDI - (01)04049539070135(10)301 ->Version 4.2-> UDI - (01)04049539070135(10)420
Carl Zeiss Meditec AG
2.0
In Commercial Distribution

  • 04049539070135 ()


  • Multidisciplinary medical image management software

DANmed - 04251351105326

LAP-Instrument, Ø10mm, l=450mm, detach. Grasping forceps TENACULUM, d/a Stainl.steel handle, insul., w/o ratchethttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
DANNORITZER Medizintechnik GmbH & Co. KG
LMC-148-345
Not in Commercial Distribution

  • 04251351105326 ()
LMC-148-345

  • Rigid endoscopic tissue manipulation forceps, reusable

NA - 07630031759061

Novaloc® Equipment Box with 3 Instruments, PP / PS / stainless steel / AI
Institut Straumann AG
Non-invasive Instruments
In Commercial Distribution

  • 07630031759061 ()
2010.101-NOV

  • Dental precision attachment fitting/adjustment tool

NA - 07630031759054

Optiloc® Equipment Box with 3 Instruments, PP / PS / stainless steel / AI
Institut Straumann AG
Non-invasive Instruments
In Commercial Distribution

  • 07630031759054 ()
5102.0000-OPT

  • Dental precision attachment fitting/adjustment tool

Tissue-VIP® 6 AI - 04946433600584

Vacuum Infiltration Processor, 230 VAC, 50/60 Hz, 6.0 Amps
SAKURA FINETEK U.S.A., INC.
6042
In Commercial Distribution

  • 04946433600584 ()


  • Tissue processor IVD, automated/semi-automated

Gcmedica - 06970754498467

No Description
GCMEDICA ENTERPRISE LTD. (WUXI)
GC0654DD
In Commercial Distribution

  • 06970754498467 ()


  • Fluid transfer set, general-purpose

De Soutter Medical - 06970754496777

No Description
GCMEDICA ENTERPRISE LTD. (WUXI)
GC1433C1U
In Commercial Distribution

  • 06970754494759 ()
  • 06970754496777 ()
  • 06970754494766 ()


  • Surgical/emergency suction cannula, non-illuminating, single-use

Natus - 06970754496623

No Description
GCMEDICA ENTERPRISE LTD. (WUXI)
GC8022F03
In Commercial Distribution

  • 06970754496586 ()
  • 06970754496623 ()
1420040,Infant,52CM*2+92CM,Clear

  • Nasal oxygen cannula, basic
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