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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No Description
KaVo Dental GmbH
1.008.4998
In Commercial Distribution

  • EKAV100849980 ()
E31 C

  • Dental power tool system handpiece, line-powered
No Description
KaVo Dental GmbH
1.008.1835
In Commercial Distribution

  • EKAV100818350 ()
L22

  • Dental power tool system handpiece, line-powered
No Description
KaVo Dental GmbH
1.008.1834
In Commercial Distribution

  • EKAV100818340 ()
L68 B

  • Dental power tool system handpiece, line-powered
No Description
KaVo Dental GmbH
1.008.1833
In Commercial Distribution

  • EKAV100818330 ()
L68

  • Dental power tool system handpiece, line-powered
This is a medical device.This is a medical device.
KaVo Dental GmbH
1.008.1832
In Commercial Distribution

  • EKAV100818320 ()
L67

  • Dental power tool system handpiece, line-powered
No Description
KaVo Dental GmbH
1.008.1831
In Commercial Distribution

  • EKAV100818310 ()
L66 B

  • Dental power tool system handpiece, line-powered
No Description
KaVo Dental GmbH
1.008.1830
In Commercial Distribution

  • EKAV100818300 ()
L62

  • Dental power tool system handpiece, line-powered
No Description
KaVo Dental GmbH
1.008.1829
In Commercial Distribution

  • EKAV100818290 ()
L61 R

  • Dental power tool system handpiece, line-powered
No Description
KaVo Dental GmbH
1.008.1826
In Commercial Distribution

  • EKAV100818260 ()
L53

  • Dental power tool system handpiece, line-powered
No Description
KaVo Dental GmbH
1.008.1825
In Commercial Distribution

  • EKAV100818250 ()
L52

  • Dental power tool system handpiece, line-powered
No Description
KaVo Dental GmbH
1.008.1824
In Commercial Distribution

  • EKAV100818240 ()
L31

  • Dental power tool system handpiece, line-powered
No Description
KaVo Dental GmbH
1.008.1823
In Commercial Distribution

  • EKAV100818230 ()
L3 Y

  • Dental power tool system handpiece, line-powered
No Description
KaVo Dental GmbH
1.008.1822
In Commercial Distribution

  • EKAV100818220 ()
L3

  • Dental power tool system handpiece, line-powered
This is a medical device.This is a medical device.
KaVo Dental GmbH
1.004.6403
In Commercial Distribution

  • EKAV100464030 ()
19 E

  • Dental power tool system handpiece, line-powered
This is a medical device.This is a medical device.
KaVo Dental GmbH
1.004.6401
In Commercial Distribution

  • EKAV100464010 ()
80 E

  • Dental power tool system handpiece, line-powered
This is a medical device.This is a medical device.
KaVo Dental GmbH
1.004.5400
In Commercial Distribution

  • EKAV100454000 ()
5000 BY

  • Dental power tool system handpiece, line-powered
This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
1.004.5380
In Commercial Distribution

  • EKAV100453800 ()
23 ES

  • Dental power tool system handpiece, line-powered
This is a medical device.This is a medical device.
KaVo Dental GmbH
1.004.4503
In Commercial Distribution

  • EKAV100445030 ()
19 ES

  • Dental power tool system handpiece, line-powered
This is a medical device.This is a medical device.
KaVo Dental GmbH
1.004.4456
In Commercial Distribution

  • EKAV100444560 ()
L80

  • Dental power tool system handpiece, line-powered
This is a medical device.
KaVo Dental GmbH
1.004.4375
In Commercial Distribution

  • EKAV100443750 ()
80 ES

  • Dental power tool system handpiece, line-powered
This is a medical device.
KaVo Dental GmbH
1.003.6977
In Commercial Distribution

  • EKAV100369770 ()
10 E

  • Dental power tool system handpiece, line-powered
No Description
KaVo Dental GmbH
1.003.6976
In Commercial Distribution

  • EKAV100369760 ()
31 E

  • Dental power tool system handpiece, line-powered
This is a medical device.The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.
KaVo Dental GmbH
1.003.1109
In Commercial Distribution

  • EKAV100311090 ()
31 ES

  • Dental power tool system handpiece, line-powered
This is a medical device.The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.The ELECTROmatic dental control unit is a stand-alone system for operating electrically-driven KaVo handpieces. External power supply provides electric power to the unit. The 4-hole tubing connected to the unit supplies chip /cooling air, water and pressure signal. The speed of the electric handpiece is controlled by air pressure. The control unit is positioned close to a treatment unit at thelocation preferred by the dentist. The ELECTROmatic system consists of a base unit with a motor hose, an electrical motor, a transformer, and a power cord. The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.
KaVo Dental GmbH
1.003.1107
In Commercial Distribution

  • EKAV100311070 ()
20 E

  • Dental power tool system handpiece, line-powered
This is a medical device.This is a medical device.
KaVo Dental GmbH
1.002.3693
In Commercial Distribution

  • EKAV100236930 ()
CL 3 09

  • Dental power tool system handpiece, line-powered
This is a medical device.This is a medical device.
KaVo Dental GmbH
1.002.2179
In Commercial Distribution

  • EKAV100221790 ()
plus 360

  • Dental power tool system handpiece, line-powered
This is a medical device.This is a medical device.
KaVo Dental GmbH
1.002.0911
In Commercial Distribution

  • EKAV100209110 ()
CL 10

  • Dental power tool system handpiece, line-powered
This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
1.001.8993
In Commercial Distribution

  • EKAV100189930 ()
CL 3

  • Dental power tool system handpiece, line-powered
No Description
KaVo Dental GmbH
1.001.7453
In Commercial Distribution

  • EKAV100174530 ()
20 LP

  • Dental power tool system handpiece, line-powered
No Description
KaVo Dental GmbH
1.001.4503
In Commercial Distribution

  • EKAV100145030 ()
C 3

  • Dental power tool system handpiece, line-powered
This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
1.001.2278
In Commercial Distribution

  • EKAV100122780 ()
C09

  • Dental power tool system handpiece, line-powered
No Description
KaVo Dental GmbH
1.007.5551
In Commercial Distribution

  • EKAV100755510 ()
E25 C

  • Dental power tool system handpiece, line-powered
This is a medical device.
KaVo Dental GmbH
1.007.5550
In Commercial Distribution

  • EKAV100755500 ()
E25 L

  • Dental power tool system handpiece, line-powered
This is a medical device.
KaVo Dental GmbH
1.007.5540
In Commercial Distribution

  • EKAV100755400 ()
E20 L

  • Dental power tool system handpiece, line-powered
No Description
KaVo Dental GmbH
1.007.5531
In Commercial Distribution

  • EKAV100755310 ()
E15 C

  • Dental power tool system handpiece, line-powered
No Description
KaVo Dental GmbH
1.007.5530
In Commercial Distribution

  • EKAV100755300 ()
E15 L

  • Dental power tool system handpiece, line-powered
This is a medical device.
KaVo Dental GmbH
1.007.3570
In Commercial Distribution

  • EKAV100735700 ()
200XDR

  • Dental power tool system handpiece, line-powered
CANNULA 98000-155 BIO-MED VEN 23 EA 17L
MEDTRONIC, INC.
98000-155
Not in Commercial Distribution

  • 00643169449053 ()

  • Catheter Gauge: 23.0 French
  • Length: 38.0 Centimeter


  • Cardiopulmonary bypass cannula, femoral
CANNULA CB98005-138 BIO-MED 23FR VEN KIT
MEDTRONIC, INC.
CB98005-138
Not in Commercial Distribution

  • 00613994608475 ()

  • Catheter Gauge: 23.0 French
  • Length: 25.0 Centimeter


  • Cardiopulmonary bypass cannula, femoral
CANN CB96345-029 BIO-MED 29FR
MEDTRONIC, INC.
CB96345-029
Not in Commercial Distribution

  • 00613994622518 ()

  • Catheter Gauge: 29.0 French
  • Length: 50.0 Centimeter


  • Cardiopulmonary bypass cannula, femoral
CANNULA CB98005-140 BIO-MED 17FR VEN KIT
MEDTRONIC, INC.
CB98005-140
Not in Commercial Distribution

  • 00613994608451 ()

  • Catheter Gauge: 17.0 French
  • Length: 25.0 Centimeter


  • Cardiopulmonary bypass cannula, femoral
The ZEUS ELISA Thyroglobulin (Tg) IgG Test System is intended for the qualitative and semi-quantitative detection of IgG-class antibody to thyroglobulin in human serum. The test system is intended to be used as an aid in the diagnosis of thyroid diseases. This test is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
2Z5061G
In Commercial Distribution

  • 00845533001175 ()
2Z5061G

  • Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
TG-300
In Commercial Distribution

  • 00816870020198 ()

  • Width: 2 Inch
TG-300

  • Thyroglobulin antibody IVD, control
No Description
OSANG HEALTHCARE Co., Ltd.
ILM-0001A
In Commercial Distribution

  • 08809115905444 ()


  • Total cholesterol lipid IVD, kit, chemiluminescent immunoassay, rapid
No Description
Berman Instruments LLC
CKP13
Not in Commercial Distribution

  • 00810060722206 ()


  • Periodontal hoe
STERILE DISPOSABLE EQUIPMENT COVERS - TABLE COVER 24" X 24"
PREFERRED MEDICAL PRODUCTS, LLC
PD-2424
In Commercial Distribution

  • 00680211002828 ()
  • 30680211002829 ()
  • 10680211002825 ()
PD-2424

  • Patient surgical drape, single-use
24" x 24" - Sterilization Wrap for Steam / ETO / Gamma
UNIPACK MEDICAL CORPORATION
UPP-2424
Not in Commercial Distribution

  • D784UPP24241 ()
  • D784UPP24240 ()
UPP-2424

  • Sterilization packaging, single-use
RTLPB-OS (BLANKET, .5MM TRUELITE, PROTECTIVE BLANKET, 24" X 24")
BURLINGTON MEDICAL, LLC
RTLPB-OS
In Commercial Distribution

  • 00840331277135 ()


  • Radiation shielding head wear
RPRPB-SM(BLANKET, .5MM PRESTIGE, PROTECTIVE BLANKET, 24" X 24")
BURLINGTON MEDICAL, LLC
RPRPB-SM
In Commercial Distribution

  • 00840331275032 ()


  • Radiation shielding apron
45 Degree Positioning Wedge 24" X 24" X 12.5"
GENEVA HEALTHCARE, LLC
30-230-00
In Commercial Distribution

  • 00810044960372 ()
  • 10810044960379 ()
30-230-00

  • Freestanding patient positioner, single-use
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