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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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Clearblue - 00633472602375

A convenience kit consisting of 15 Digital Ovulation Tests, Digital Basal Thermometer and 3 month subscription to Natural Cycles app
SPD SWISS PRECISION DIAGNOSTICS GMBH
Birth Control Kit
In Commercial Distribution

  • 10633472602372 ()
  • 00633472602375 ()
N/A

  • Natural conception assistance kit

OTIS-C PLUS - 03760154004152

NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
S.B.M
NON STERILE Screw for OTIS-C PLUS plate fixation
Not in Commercial Distribution

  • 03760154004152 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 70 Millimeter
EVONS66070

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Best Medical International - 00841365115394

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageSize=25&pageMode=read+only&currentPage=0&deviceRecordKey=141332#
BEST MEDICAL INTERNATIONAL, INC.
1164-1-40
In Commercial Distribution

  • 00841365115394 ()


  • General-purpose brachytherapy system applicator, remote-afterloading

Liquichek - 00847661003793

Liquichek Reticulocyte Control (A-I) Bilevel MiniPak (An assayed reticulocyte control.)
BIO-RAD LABORATORIES, INC.
915X
In Commercial Distribution

  • 00847661003793 ()
915X

  • Reticulocyte count IVD, control

Liquichek - 00847661003786

Liquichek Reticulocyte Control (A-I) Level 2 (An assayed reticulocyte control.)
BIO-RAD LABORATORIES, INC.
917
In Commercial Distribution

  • 00847661003786 ()
917

  • Reticulocyte count IVD, control

Liquichek - 00847661003779

Liquichek Reticulocyte Control (A-I) Level 1 (An assayed reticulocyte control.)
BIO-RAD LABORATORIES, INC.
916
In Commercial Distribution

  • 00847661003779 ()
916

  • Reticulocyte count IVD, control

Stethophone Pro - 00860011561729

Smartphone stethoscope software application with AI for iPhones - Rx only
Sparrow Acoustics Inc.
3.x.x
In Commercial Distribution

  • 00860011561729 ()


  • Electronic acoustic stethoscope

Millennium - 00190776189402

LED Lightsource with port light turrent: AI Wf Storz ympus
Avalign Technologies, Inc.
72-983000
In Commercial Distribution

  • 00190776189402 ()


  • Endoscopic light source unit, line-powered

Millennium - 00190776209315

ADAPTERSNAP ON AI TO STORZ ADAPTER AND STRYKER TO STORZ
Avalign Technologies, Inc.
72-5251ACMIST
In Commercial Distribution

  • 00190776209315 ()


  • Luer/non-ISO80369-standardized linear connector, reusable

N Apolipoprotein Standard Serum - 00842768011535

Calibration of apolipoprotein A-I and B assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446466
In Commercial Distribution

  • 00842768011535 ()
  • 00842768018602 ()
OUPG09

  • Plasma protein IVD, calibrator
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