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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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A 3.5
PEARSON DENTAL SUPPLIES, INC.
S270014
In Commercial Distribution

  • D724S2700141 ()


  • Temporary dental crown/bridge resin
N/A
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555513045045 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 45 Millimeter
51-3045-045

  • Bone-screw internal spinal fixation system, non-sterile
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)
The Accula™ Flu A / B Test performed on the Accula 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 Accula Flu A / B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. Accula Flu 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.
FAB1100CW
In Commercial Distribution

  • B540FAB1100CW0 ()
FAB1100CW

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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.
1035
In Commercial Distribution

  • B54010350 ()
1035

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Bur, Surgical, General & Plastic Surgery
Jota AG
CX162A.HP.016
In Commercial Distribution

  • EJOT50010440901901601 ()
  • EJOT500104409019016 ()


  • Orthopaedic bur, reusable
Burr, Orthopedic
Jota AG
CX73.HP.060
In Commercial Distribution

  • EJOT500104277190060 ()


  • Carbide dental bur, reusable
Burr, Orthopedic
Jota AG
CX251G.HP.060
In Commercial Distribution

  • EJOT500104274220060 ()


  • Carbide dental bur, reusable
Burr, Orthopedic
Jota AG
CX251.HP.060
In Commercial Distribution

  • EJOT500104274190060 ()


  • Carbide dental bur, reusable
Burr, Orthopedic
Jota AG
CX251F.HP.060
In Commercial Distribution

  • EJOT500104274140060 ()


  • Carbide dental bur, reusable
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