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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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ACIF - 14mm x 5mm x 5° Curvo
Tyber Medical LLC
MC2-C14552-S
In Commercial Distribution

  • M695502C14552S0 ()
MC2-C14552-S

  • Metal-polymer composite spinal interbody fusion cage
Partial Extraction Technique Kit
Hager & Meisinger Gesellschaft mit beschränkter Haftung
WPP21
In Commercial Distribution

  • E0HM79WPP211 ()
WPP21

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Mini-invasive extraction & SSA kit by Dr Gary Finelle & Pr France Lambert
Hager & Meisinger Gesellschaft mit beschränkter Haftung
SSA01
In Commercial Distribution

  • E0HM740SSA011 ()
SSA01

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Sterile Cabide Round ,2,3 RA
Hager & Meisinger Gesellschaft mit beschränkter Haftung
6736-383
In Commercial Distribution

  • E0HM266736383BE00101 ()
  • E0HM266736383BE001 ()
6736-383

  • Carbide dental bur, single-use
Sterile Cabide Round ,1,8 RA
Hager & Meisinger Gesellschaft mit beschränkter Haftung
6736-338
In Commercial Distribution

  • E0HM266736338BE00101 ()
  • E0HM266736338BE001 ()
6736-338

  • Carbide dental bur, single-use
Sterile Cabide Round ,1,0 RA
Hager & Meisinger Gesellschaft mit beschränkter Haftung
6736-285
In Commercial Distribution

  • E0HM266736285BE00101 ()
  • E0HM266736285BE001 ()
6736-285

  • Carbide dental bur, single-use
Sterile Cabide Round ,2,3 FG
Hager & Meisinger Gesellschaft mit beschränkter Haftung
6736-230
In Commercial Distribution

  • E0HM266736230BE00101 ()
  • E0HM266736230BE001 ()
6736-230

  • Carbide dental bur, single-use
Sterile Cabide Round ,1,0 FG
Hager & Meisinger Gesellschaft mit beschränkter Haftung
6735-268
In Commercial Distribution

  • E0HM266735268BE00101 ()
  • E0HM266735268BE001 ()
6735-268

  • Carbide dental bur, single-use
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)
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