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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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MGB Alert Internal Control Set IC2-T - 03661540950247

The MGB Alert Internal Control Set IC2-T consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2-T can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes.
Elitechgroup Mdx LLC
M800580
In Commercial Distribution

  • 03661540950247 ()
M800580

  • Exogenous DNA/RNA internal control IVD, kit

MGB Alert Internal Control Set IC1-A, 09N40-001 - 03661540950186

The MGB Alert Internal Control Set IC1-A consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC1-A can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes.
Elitechgroup Mdx LLC
800495-am
In Commercial Distribution

  • 03661540950186 ()
800495-am

  • Exogenous DNA/RNA internal control IVD, kit

MGB Alert Internal Control Set IC1, 09N39-001 - 03661540950155

The MGB Alert Internal Control Set IC1 consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC1 can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes.
Elitechgroup Mdx LLC
800427-am
In Commercial Distribution

  • 03661540950155 ()
800427-am

  • Exogenous DNA/RNA internal control IVD, kit

Instrument Adapter, Starlock V2012 - 04056481005368

No Description
Brainlab AG
55085
In Commercial Distribution

  • 04056481005368 ()
55085

  • Robotic surgical navigation system

Convey - 08714729853763

The Hydrophilic Coated Guiding Catheter is a single use device that facilitates the passage of intravascular devices. Two (2) Side Holes in the Tip Section.
PendraCare International B.V.
8F Convey AL1.5 SH
In Commercial Distribution

  • 08714729853763 ()

  • 8F Diameter
  • Two (2) Side Holes in Tip Section.
  • Length: 100 Centimeter
H74939266890

  • Vascular guide-catheter, single-use

Convey - 08714729853725

The Hydrophilic Coated Guiding Catheter is a single use device that facilitates the passage of intravascular devices. Two (2) Side Holes in the Tip Section.
PendraCare International B.V.
8F Convey MPA SH
In Commercial Distribution

  • 08714729853725 ()

  • Length: 100 Centimeter
  • Two (2) Side Holes in Tip Section.
  • 8F Diameter
H749392667680

  • Vascular guide-catheter, single-use

Convey - 08714729853596

The Hydrophilic Coated Guiding Catheter is a single use device that facilitates the passage of intravascular devices. Two (2) Side Holes in the Tip Section.
PendraCare International B.V.
8F Convey RC5 SC SH
In Commercial Distribution

  • 08714729853596 ()

  • 8F Diameter
  • Two (2) Side Holes in Tip Section.
  • Length: 100 Centimeter
H749392667550

  • Vascular guide-catheter, single-use

Convey - 08714729853589

The Hydrophilic Coated Guiding Catheter is a single use device that facilitates the passage of intravascular devices. Two (2) Side Holes in the Tip Section.
PendraCare International B.V.
8F Convey ART4.25 SH
In Commercial Distribution

  • 08714729853589 ()

  • Length: 100 Centimeter
  • Two (2) Side Holes in Tip Section.
  • 8F Diameter
H749392667540

  • Vascular guide-catheter, single-use

Convey - 08714729853572

The Hydrophilic Coated Guiding Catheter is a single use device that facilitates the passage of intravascular devices. Two (2) Side Holes in the Tip Section.
PendraCare International B.V.
8F Convey ART3.75 SH
In Commercial Distribution

  • 08714729853572 ()

  • Length: 100 Centimeter
  • Two (2) Side Holes in Tip Section.
  • 8F Diameter
H749392667530

  • Vascular guide-catheter, single-use

Convey - 08714729853565

The Hydrophilic Coated Guiding Catheter is a single use device that facilitates the passage of intravascular devices. Two (2) Side Holes in the Tip Section.
PendraCare International B.V.
8F Convey LeftBU4.75 SH
In Commercial Distribution

  • 08714729853565 ()

  • Length: 100 Centimeter
  • Two (2) Side Holes in Tip Section.
  • 8F Diameter
H749392667520

  • Vascular guide-catheter, single-use
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