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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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Artic 6, A3 / TO 30, CE - J014660128840

Artifical Teeth, resin
Kulzer GmbH
66012884
In Commercial Distribution

  • J014660128840 ()
66012884

  • Resin artificial teeth

Artic 6, A2 / TO 30, CE - J014660128830

Artifical Teeth, resin
Kulzer GmbH
66012883
In Commercial Distribution

  • J014660128830 ()
66012883

  • Resin artificial teeth

microTargeting™ USB to Serial Adapter - 00873263002858

microTargeting USB to Serial Adaptor, for use with microTargeting Controller
FHC, INC.
MT-LPP-CONV-00285
In Commercial Distribution

  • 00873263002858 ()
MT-LPP-CONV

  • Neurophysiologic monitoring system

Artic 6, D4 / TO 10, CE - J014660150920

Artifical Teeth, resin
Kulzer GmbH
66015092
In Commercial Distribution

  • J014660150920 ()
66015092

  • Resin artificial teeth

Artic 6, D3 / TO 20, CE - J014660150770

Artifical Teeth, resin
Kulzer GmbH
66015077
In Commercial Distribution

  • J014660150770 ()
66015077

  • Resin artificial teeth

Artic 6, D3 / TO 05, CE - J014660150750

Artifical Teeth, resin
Kulzer GmbH
66015075
In Commercial Distribution

  • J014660150750 ()
66015075

  • Resin artificial teeth

Artic 6, D2 / TO 20, CE - J014660150610

Artifical Teeth, resin
Kulzer GmbH
66015061
In Commercial Distribution

  • J014660150610 ()
66015061

  • Resin artificial teeth

Artic 6, C4 / TO 10, CE - J014660150440

Artifical Teeth, resin
Kulzer GmbH
66015044
In Commercial Distribution

  • J014660150440 ()
66015044

  • Resin artificial teeth

Artic 6, C3 / TO 20, CE - J014660150290

Artifical Teeth, resin
Kulzer GmbH
66015029
In Commercial Distribution

  • J014660150290 ()
66015029

  • Resin artificial teeth

Artic 6, C3 / TO 10, CE - J014660150280

Artifical Teeth, resin
Kulzer GmbH
66015028
In Commercial Distribution

  • J014660150280 ()
66015028

  • Resin artificial teeth

Artic 6, C3 / TO 05, CE - J014660150270

Artifical Teeth, resin
Kulzer GmbH
66015027
In Commercial Distribution

  • J014660150270 ()
66015027

  • Resin artificial teeth

Artic 6, C2 / TO 20, CE - J014660150130

Artifical Teeth, resin
Kulzer GmbH
66015013
In Commercial Distribution

  • J014660150130 ()
66015013

  • Resin artificial teeth

Artic 6, C2 / TO 05, CE - J014660150110

Artifical Teeth, resin
Kulzer GmbH
66015011
In Commercial Distribution

  • J014660150110 ()
66015011

  • Resin artificial teeth

Artic 6, B4 / TO 10, CE - J014660149800

Artifical Teeth, resin
Kulzer GmbH
66014980
In Commercial Distribution

  • J014660149800 ()
66014980

  • Resin artificial teeth

Artic 6, B3 / TO 10, CE - J014660149640

Artifical Teeth, resin
Kulzer GmbH
66014964
In Commercial Distribution

  • J014660149640 ()
66014964

  • Resin artificial teeth

Artic 6, B3 / TO 05, CE - J014660149630

Artifical Teeth, resin
Kulzer GmbH
66014963
In Commercial Distribution

  • J014660149630 ()
66014963

  • Resin artificial teeth

Artic 6, B2 / TO 20, CE - J014660149490

Artifical Teeth, resin
Kulzer GmbH
66014949
In Commercial Distribution

  • J014660149490 ()
66014949

  • Resin artificial teeth

Artic 6, B2 / TO 05, CE - J014660149470

Artifical Teeth, resin
Kulzer GmbH
66014947
In Commercial Distribution

  • J014660149470 ()
66014947

  • Resin artificial teeth

Artic 6, B1 / TO 20, CE - J014660149330

Artifical Teeth, resin
Kulzer GmbH
66014933
In Commercial Distribution

  • J014660149330 ()
66014933

  • Resin artificial teeth

Artic 6, B1 / TO 05, CE - J014660149310

Artifical Teeth, resin
Kulzer GmbH
66014931
In Commercial Distribution

  • J014660149310 ()
66014931

  • Resin artificial teeth

Artic 6, A4 / TO 10, CE - J014660149160

Artifical Teeth, resin
Kulzer GmbH
66014916
In Commercial Distribution

  • J014660149160 ()
66014916

  • Resin artificial teeth

Artic 6, C4 / TO 40, CE - J014660140690

Artifical Teeth, resin
Kulzer GmbH
66014069
In Commercial Distribution

  • J014660140690 ()
66014069

  • Resin artificial teeth

Artic 6, C3 / TO 40, CE - J014660140680

Artifical Teeth, resin
Kulzer GmbH
66014068
In Commercial Distribution

  • J014660140680 ()
66014068

  • Resin artificial teeth

Artic 6, C1 / TO 40, CE - J014660140670

Artifical Teeth, resin
Kulzer GmbH
66014067
In Commercial Distribution

  • J014660140670 ()
66014067

  • Resin artificial teeth

Artic 6, B4 / TO 40, CE - J014660140660

Artifical Teeth, resin
Kulzer GmbH
66014066
In Commercial Distribution

  • J014660140660 ()
66014066

  • Resin artificial teeth

Artic 6, B3 / TO 40, CE - J014660140650

Artifical Teeth, resin
Kulzer GmbH
66014065
In Commercial Distribution

  • J014660140650 ()
66014065

  • Resin artificial teeth

Artic 6, A4 / TO 40, CE - J014660140640

Artifical Teeth, resin
Kulzer GmbH
66014064
In Commercial Distribution

  • J014660140640 ()
66014064

  • Resin artificial teeth

Artic 6, D4 / TO 30, CE - J014660140630

Artifical Teeth, resin
Kulzer GmbH
66014063
In Commercial Distribution

  • J014660140630 ()
66014063

  • Resin artificial teeth

Artic 6, D3 / TO 30, CE - J014660140620

Artifical Teeth, resin
Kulzer GmbH
66014062
In Commercial Distribution

  • J014660140620 ()
66014062

  • Resin artificial teeth

Artic 6, D2 / TO 30, CE - J014660140610

Artifical Teeth, resin
Kulzer GmbH
66014061
In Commercial Distribution

  • J014660140610 ()
66014061

  • Resin artificial teeth

Artic 6, C4 / TO 30, CE - J014660140600

Artifical Teeth, resin
Kulzer GmbH
66014060
In Commercial Distribution

  • J014660140600 ()
66014060

  • Resin artificial teeth

Artic 6, C3 / TO 30, CE - J014660140590

Artifical Teeth, resin
Kulzer GmbH
66014059
In Commercial Distribution

  • J014660140590 ()
66014059

  • Resin artificial teeth

Artic 6, C1 / TO 30, CE - J014660140580

Artifical Teeth, resin
Kulzer GmbH
66014058
In Commercial Distribution

  • J014660140580 ()
66014058

  • Resin artificial teeth

Artic 6, B4 / TO 30, CE - J014660140570

Artifical Teeth, resin
Kulzer GmbH
66014057
In Commercial Distribution

  • J014660140570 ()
66014057

  • Resin artificial teeth

Artic 6, B3 / TO 30, CE - J014660140560

Artifical Teeth, resin
Kulzer GmbH
66014056
In Commercial Distribution

  • J014660140560 ()
66014056

  • Resin artificial teeth

Artic 6, A4 / TO 30, CE - J014660140550

Artifical Teeth, resin
Kulzer GmbH
66014055
In Commercial Distribution

  • J014660140550 ()
66014055

  • Resin artificial teeth

Artic 6, C2 / TO 40, CE - J014660128950

Artifical Teeth, resin
Kulzer GmbH
66012895
In Commercial Distribution

  • J014660128950 ()
66012895

  • Resin artificial teeth

Artic 6, B1 / TO 40, CE - J014660128930

Artifical Teeth, resin
Kulzer GmbH
66012893
In Commercial Distribution

  • J014660128930 ()
66012893

  • Resin artificial teeth

Artic 6, A1 / TO 40, CE - J014660128890

Artifical Teeth, resin
Kulzer GmbH
66012889
In Commercial Distribution

  • J014660128890 ()
66012889

  • Resin artificial teeth

Artic 6, A3.5 / TO 30, CE - J014660128850

Artifical Teeth, resin
Kulzer GmbH
66012885
In Commercial Distribution

  • J014660128850 ()
66012885

  • Resin artificial teeth

Artic 6, A1 / TO 30, CE - J014660128820

Artifical Teeth, resin
Kulzer GmbH
66012882
In Commercial Distribution

  • J014660128820 ()
66012882

  • Resin artificial teeth

PIN LEAD TO GRASP CLIP ADAPTOR - 14897076721020

No Description
TENS PLUS INDUSTRIAL COMPANY
Ez.Grip.6
In Commercial Distribution

  • 14897076721020 ()


  • Transcutaneous electrical stimulation lead

GoldN Easy to Use FSH Test - 00850059915370

The GoldN™ Easy to Use FSH Test is a rapid immunochromatographic assay for the qualitative detection of follicle-stimulating hormone (FSH) in urine to aid women in the assessment of the onset of menopause.
NOVODX Corporation
GN011ST02-US
In Commercial Distribution

  • 00850059915370 ()
GN011ST

  • Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing

GoldN Easy to Use Ovulation Test - 00850059915646

The GoldNTM Easy to Use Ovulation Test is a rapid chromatographic immunoassay for the qualitative detection of Luteinizing Hormone (LH) surge in urine to predict the time of ovulation. The test is intended for women who want to conceive. For in vitro diagnostic use. For over-the-counter use.
NOVODX Corporation
GN013ST10-US
In Commercial Distribution

  • 00850059915646 ()
GN013ST

  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical

GoldN Easy to Use Pregnancy Test - 00850059915639

The GoldNTM Easy to Use Pregnancy Test is a rapid, visual immunoassay for the qualitative detection of human chorionic gonadotropin(hCG) in urine. The test is an in vitro diagnostic device intended for use as an aid in the early detection of pregnancy. The GoldNTM Easy to Use Pregnancy Test is designed for self-testing use.
NOVODX Corporation
GN040ST02-US
In Commercial Distribution

  • 00850059915639 ()
GN040ST

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

Artic 6, BL3 / TO 20, CE - J014669704300

Artifical Teeth, resin
Kulzer GmbH
66970430
In Commercial Distribution

  • J014669704300 ()
66970430

  • Resin artificial teeth

Artic 6, BL3 / TO 10, CE - J014669704290

Artifical Teeth, resin
Kulzer GmbH
66970429
In Commercial Distribution

  • J014669704290 ()
66970429

  • Resin artificial teeth

Artic 6, BL3 / TO 05, CE - J014669704280

Artifical Teeth, resin
Kulzer GmbH
66970428
In Commercial Distribution

  • J014669704280 ()
66970428

  • Resin artificial teeth

Artic 6, BL3 / TO 40, CE - J014669704140

Artifical Teeth, resin
Kulzer GmbH
66970414
In Commercial Distribution

  • J014669704140 ()
66970414

  • Resin artificial teeth

Artic 6, BL3 / TO 30, CE - J014669704130

Artifical Teeth, resin
Kulzer GmbH
66970413
In Commercial Distribution

  • J014669704130 ()
66970413

  • Resin artificial teeth
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