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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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Silaris Influenza A&B Test - B54010270

The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Silaris Influenza A&B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. Silaris Influenza A&B assay is intended as an aid in the diagnosis of influenza infections in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.
MESA BIOTECH, INC.
1027
In Commercial Distribution

  • B54010270 ()
1027

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

SONICflex rootplaner Tip No. 25 - EKAV057156310

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
0.571.5631
In Commercial Distribution

  • EKAV057156310 ()
rootplaner Tip No 25

  • Ultrasonic dental scaling/debridement system

SONICflex retro, left - EKAV057156010

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
0.571.5601
In Commercial Distribution

  • EKAV057156010 ()
retro left

  • Ultrasonic dental scaling/debridement system

SONICflex scaler Tip No. 6 - EKAV057151810

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
0.571.5181
In Commercial Distribution

  • EKAV057151810 ()
scaler Tip No 6

  • Ultrasonic dental scaling/debridement system

SONICflex prep ceram Tip No. 52 A - EKAV100619860

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
1.006.1986
In Commercial Distribution

  • EKAV100619860 ()
prep ceram Tip No 52 A

  • Ultrasonic dental scaling/debridement system

INTRAmatic 23 ES - EKAV100453800

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

CAD-CAM mesial gebogen No. 34 - EKAV100219840

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
1.002.1984
In Commercial Distribution

  • EKAV100219840 ()
mesial gebogen No 34

  • Ultrasonic dental scaling/debridement system

INTRA Head CL 3 - EKAV100189930

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

INTRA Handpiece C09 - EKAV100122780

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

SONICflex cari-ex TC Tipset - EKAV100073790

This is a medical device.This is a medical device.This is a medical device.
KaVo Dental GmbH
1.000.7379
In Commercial Distribution

  • EKAV100073790 ()
cari ex TC Tipset

  • Ultrasonic dental scaling/debridement system
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