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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CARESCAPE ONE MBZ323 ATO MODEL
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
MBZ323
In Commercial Distribution

  • 00195278288639 ()
2087075-300

  • Multiple vital physiological parameter monitoring system, clinical
G-CEM ONE Single Refill White Opaque GCA
Gc America Inc.
013676
In Commercial Distribution

  • D0470136761 ()
013676

  • Dental composite resin
G-CEM ONE Single Refill AO3 GCA
Gc America Inc.
013675
In Commercial Distribution

  • D0470136751 ()
013675

  • Dental composite resin
G-CEM ONE Twin Refill Translucent GCA
Gc America Inc.
013674
In Commercial Distribution

  • D0470136741 ()
013674

  • Dental composite resin
G-CEM ONE Twin Refill A2 GCA
Gc America Inc.
013673
In Commercial Distribution

  • D0470136731 ()
013673

  • Dental composite resin
G-CEM ONE System Kit GCA
Gc America Inc.
031672
In Commercial Distribution

  • D0470136721 ()
013672

  • Dental composite resin
G-CEM ONE Starter Kit Translucent GCA
Gc America Inc.
013671
In Commercial Distribution

  • D0470136711 ()
013671

  • Dental composite resin
G-CEM ONE Starter Kit A2 GCA
Gc America Inc.
013670
In Commercial Distribution

  • D0470136701 ()
013670

  • Dental composite resin
G-CEM ONE Adhesive Enhancing Primer GCA
Gc America Inc.
013642
In Commercial Distribution

  • D0470136421 ()
013642

  • Dental composite resin
No Description
Athelas, Inc.
850-00001-00
In Commercial Distribution

  • 00860001013238 ()


  • Haematological cell analyser IVD
No Description
Athelas, Inc.
850-00002-00
In Commercial Distribution

  • 00860001013221 ()
  • 00860001013214 ()


  • Laboratory analyser cuvette IVD, single-use
No Description
Solace Trading LLC
CL8032 - X-Large - 100 PCS
In Commercial Distribution

  • 00860007772337 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
No Description
Solace Trading LLC
CL8032 - Large - 100 PCS
In Commercial Distribution

  • 00860007772320 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
No Description
Solace Trading LLC
CL8032 - Medium - 100 PCS
In Commercial Distribution

  • 00860007772313 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
No Description
Solace Trading LLC
CL8032 - Small - 100 PCS
In Commercial Distribution

  • 00860007772306 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Kinesia One, Tablet Assembly, WiFi
Great Lakes Neurotechnologies Inc.
502-0269, Tablet Assembly, WiFi
In Commercial Distribution

  • 00859584006010 ()


  • Tremor transducer
System Kit, Blood Glucose Meter, One Drop, mg/dL, (25ct)
INFORMED DATA SYSTEMS INC.
8000-10584
In Commercial Distribution

  • 20859509006068 ()
  • 00859509006064 ()


  • Glucose monitoring system IVD, home-use
Lancing Device, One Drop
INFORMED DATA SYSTEMS INC.
8300-10532
In Commercial Distribution

  • 00859509006057 ()


  • Manual blood lancing device, reusable
Test Strips, One Drop, 50ct
INFORMED DATA SYSTEMS INC.
8000-10510
In Commercial Distribution

  • 20859509006051 ()
  • 10859509006047 ()
  • 00859509006033 ()
  • 80859509006039 ()


  • Glucose monitoring system IVD, home-use
System Kit, Blood Glucose Meter, One Drop, mgd/L
INFORMED DATA SYSTEMS INC.
8000-10495
In Commercial Distribution

  • 10859509006023 ()
  • 00859509006026 ()


  • Glucose monitoring system IVD, home-use
Blood Glucose Meter, One Drop, mg/dL
INFORMED DATA SYSTEMS INC.
8000-10465
In Commercial Distribution

  • 00859509006019 ()


  • Glucose monitoring system IVD, home-use
Kinesia One, Application Software
Great Lakes Neurotechnologies Inc.
360-0040, Application Software
In Commercial Distribution

  • 00859584006119 ()


  • Tremor transducer
Kinesia One, Tablet Assembly, WiFi plus Cellular
Great Lakes Neurotechnologies Inc.
502-0270, Tablet Assembly, WiFi plus Cellular
In Commercial Distribution

  • 00859584006041 ()


  • Tremor transducer
Kinesia One, WiFi plus Cellular
Great Lakes Neurotechnologies Inc.
700-0019-1, WiFi plus Cellular
In Commercial Distribution

  • 00859584006034 ()


  • Tremor transducer
Kinesia One, Sensor Assembly
Great Lakes Neurotechnologies Inc.
502-0263, Sensor Assembly
In Commercial Distribution

  • 00859584006027 ()


  • Tremor transducer
Kinesia One System, WiFi
Great Lakes Neurotechnologies Inc.
700-0019, WiFi
In Commercial Distribution

  • 00859584006003 ()


  • Tremor transducer
Lancets, 33G, 100CT, Boxed, One Drop, US-UK
INFORMED DATA SYSTEMS INC.
8000-10556
In Commercial Distribution

  • 00859509006118 ()


  • Blood lancing device tip
Dual Mode Infrared Thermometer
Ahold U.S.A., Inc.
FC-IR100
In Commercial Distribution

  • 00688267567841 ()


  • Infrared patient thermometer, skin
No Description
Ahold U.S.A., Inc.
AHOST25
In Commercial Distribution

  • 30688267567583 ()
  • 00688267567582 ()
  • 10688267567589 ()


  • Menstrual pad, unscented
MAXIPAD REGULAR w/WINGS UNSCENTED
Ahold U.S.A., Inc.
600790
In Commercial Distribution

  • 10688267540162 ()
  • 00688267540165 ()
  • 00068826754019 ()


  • Menstrual pad, unscented
MAXIPAD LONG SUPER w/WINGS UNSCENTED
Ahold U.S.A., Inc.
663290
In Commercial Distribution

  • 10688267540155 ()
  • 00688267540158 ()
  • 00068826754019 ()


  • Menstrual pad, unscented
MAXIPAD OVERNIGHT w/WINGS UNSCENTED
Ahold U.S.A., Inc.
669150
In Commercial Distribution

  • 10688267540148 ()
  • 00688267540141 ()
  • 00068826754019 ()


  • Menstrual pad, unscented
MAXIPAD LONG SUPER w/WINGS UNSCENTED
Ahold U.S.A., Inc.
665610
In Commercial Distribution

  • 10688267131643 ()
  • 00688267131646 ()
  • 00068826713160 ()


  • Menstrual pad, unscented
MAXIPAD ULTRA THIN OVERNIGHT w/WINGS UNSCENTED
Ahold U.S.A., Inc.
551580
In Commercial Distribution

  • 10688267131513 ()
  • 00688267131516 ()
  • 00068826713153 ()


  • Menstrual pad, unscented
MAXIPAD OVERNIGHT w/WINGS UNSCENTED
Ahold U.S.A., Inc.
667870
In Commercial Distribution

  • 10688267039352 ()
  • 00688267039355 ()
  • 00068826703932 ()


  • Menstrual pad, unscented
MAXIPAD LONG SUPER MULTI-CHANNEL WINGLESS UNSCENTED
Ahold U.S.A., Inc.
268722
In Commercial Distribution

  • 00068826703116 ()
  • 00688267031106 ()
  • 10688267031103 ()


  • Menstrual pad, unscented
MAXIPAD LONG SUPER MULTI-CHANNEL WINGLESS UNSCENTED
Ahold U.S.A., Inc.
600810
In Commercial Distribution

  • 10688267022033 ()
  • 00688267022036 ()
  • 00068826702201 ()


  • Menstrual pad, unscented
MAXIPAD REGULAR UNSCENTED
Ahold U.S.A., Inc.
268566
In Commercial Distribution

  • 00688267022029 ()
  • 00068826702201 ()
  • 10688267022026 ()


  • Menstrual pad, unscented
PANTILINER LONG CONTOUR UNSCENTED
Ahold U.S.A., Inc.
268571
In Commercial Distribution

  • 10688267022019 ()
  • 00688267022012 ()
  • 00068826702201 ()


  • Menstrual pad, unscented
PANTILINER LONG CONTOUR UNSCENTED
Ahold U.S.A., Inc.
268462
In Commercial Distribution

  • 10688267022002 ()
  • 00688267022005 ()
  • 00068826702201 ()


  • Menstrual pad, unscented
MAXIPAD ULTRA THIN LARGE SUPER w/WINGS UNSCENTED
Ahold U.S.A., Inc.
663490
In Commercial Distribution

  • 10688267021982 ()
  • 00688267021985 ()
  • 00068826702195 ()


  • Menstrual pad, unscented
MAXIPAD ULTRA THIN OVERNIGHT w/WINGS UNSCENTED
Ahold U.S.A., Inc.
489770
In Commercial Distribution

  • 10688267021975 ()
  • 00688267021978 ()
  • 00068826702195 ()


  • Menstrual pad, unscented
No Description
Guangzhou Double One Latex Products Co., Ltd
53MM Standard
In Commercial Distribution

  • 06901691564656 ()
  • 36901691564657 ()


  • Basic male condom, Hevea-latex
No Description
EAGLE SPRINGS ENTERPRISES LLC
Hylan GF-20
Not in Commercial Distribution

  • 00864223000229 ()


  • Synovial fluid supplementation medium
This record is for BrainScope Part Number 99-1801-200 (SKU: BSO-3001) which is the BrainScope Ahead 500 CUBC1 Kit. Contains Device Identifier (DI) 00852745007277 - this is the DI for the BrainScope One (CUBC1) Device (BrainScope Part Number 50-1801-203)
Brainscope Company, Inc.
Ahead 500 CUBC1
In Commercial Distribution

  • 00852745007284 ()
BSO-3001

  • Electroencephalograph
BrainScope Part Number 99-1801-100 (SKU: BSO-2001) Contains Device Identifier (DI) 00852745007222 - this is the DI for the BrainScope One Device.
Brainscope Company, Inc.
Ahead 500
In Commercial Distribution

  • 00852745007239 ()
BSO-2001

  • Electroencephalograph
No Description
Brainscope Company, Inc.
99-1403-002
In Commercial Distribution

  • 00852745007123 ()


  • Electroencephalograph
Intraoral scanner w. protection tip
3shape Trios A/S
S3-2
Not in Commercial Distribution

  • 05902729753616 ()


  • Intraoral optical scanning system
Color pen-grip intraoral scanner w. protection tip
3shape Trios A/S
S1-2
Not in Commercial Distribution

  • 05902729753609 ()


  • Dental milling system, CAD/CAM, chairside
Cord
3shape Trios A/S
TSC-01
Not in Commercial Distribution

  • 05902729753593 ()


  • Intraoral optical scanning system
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