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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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No Description
Ceram Optec SIA
MegaBeam® Single Use Bare Fiber 600um, Flat Tip PF, ID (1x1h)
In Commercial Distribution

  • 04049089300478 ()
  • 04049089200471 ()
  • 04049089100474 ()
101015

  • General/multiple surgical laser system beam guide, single-use
No Description
Natus Medical Denmark ApS
1096, SA CLINI W/ PRIN,COM US
In Commercial Distribution

  • 05713315005664 ()
8-04-16047

  • Impedance audiometer
No Description
Natus Medical Denmark ApS
1096,SA, DIAG W/ PRIN, COM US
In Commercial Distribution

  • 05713315005619 ()
8-04-16042

  • Impedance audiometer
The RONDEX CPR VALVE Model #2020 is for emergency used only with a suitable CPR mask to help isolate the patient's breath from the rescuer. . It has a single flapper valve which stays flexible under very cold conditions. Fits masks with 15 mm OD stem or 22 mm ID opening. Made in USA
RONDEX PRODUCTS, INCORPORATED
2020 package in polybag
Not in Commercial Distribution

  • 06343760020203 ()
2020

  • Non-rebreathing valve, single-use
This adapter consists of a spike connector, approx. 10.15 cm (4 inch) long, 3.81 mm (0.150 inch) ID tubing and a flanged Easy-Lock Connector. This device is indicated for the personal cycler peritoneal dialysis system used for automatic control of dialysate solution exchanges in the treatment of renal failure patients undergoing peritoneal dialysis.
BAXTER HEALTHCARE CORPORATION
5C4136
In Commercial Distribution

  • 50085412050824 ()
  • 00085412050829 ()
5C4136

  • Peritoneal dialysis system tubing set
The RONDEX CPR ISO-VALVE Model #4040 is for emergency used only with a suitable CPR mask. It contains a total of two (2) silicone valves to help isolate the rescuer from the patient's breath. Fits masks with 15 mm OD stem or 22 mm ID opening. Made in USA (ISO-VALVE(TM) of Rondex Products, Inc.)
RONDEX PRODUCTS, INCORPORATED
4040 (packaged in polybag)
Not in Commercial Distribution

  • 06343760040409 ()
4040

  • Non-rebreathing valve, single-use
The EMPOWER RF Catheter is a monopolar endoscopic tool that is used to deliver controlled radiofrequency (RF) energy to a target site within the upper airway or tracheobronchial tree when connected to a standard electrosurgical generator. The EMPOWER RF Catheter is inserted through the bronchoscope/extended working channel of 2.0 mm ID or greater to reach the target site.
BRONCUS MEDICAL INC.
10010
In Commercial Distribution

  • 00856571007241 ()

  • Catheter Working Length: 1445 Millimeter
  • Outer Diameter: 1.8 Millimeter
10010

  • Endoscopic electrosurgical electrode, monopolar, single-use
Array Insertion Electrode/Tube with Stylet Kit, 5x, Sterile, for use with Nexframe and microTargeting Drive. Contains: IT(AR8): Insertion Tube w/ Stylet. MTDPBN(PA)(DB2): microTargeting Electrode. Individual Specifications: IT(AR8) - 217mm tube length, 0.89mm OD, 0.58mm ID MTDPBN(PA)(DB2) - 249.2mm electrode length, 10mm differential length, 234.2mm protective tube length. 1 Meg RZAP, 0.56mm od
FHC, INC.
FC7100-00756
In Commercial Distribution

  • 10873263007560 ()
  • 00873263007563 ()
FC7100

  • Depth electrode
  • Intracerebral cannula, nonimplantable, single-use
Array Insertion Electrode/Tube with Stylet Kit, 5x, Sterile, for use with Nexframe and microTargeting Drive. Contains: IT(AR8): Insertion Tube w/ Stylet. MTDPBN(PA)(DB2): microTargeting Electrode. Individual Specifications: IT(AR8) - 217mm tube length, 0.89mm OD, 0.58mm ID MTDPBN(PA)(DB2) - 249.2mm electrode length, 10mm differential length, 234.2mm protective tube length. 1 Meg RZAP, 0.56mm od
FHC, INC.
FC7100-00132
Not in Commercial Distribution

  • 10873263001322 ()
  • 00873263001325 ()
FC7100

  • Intracerebral cannula, implantable
  • Depth electrode
Adult Flexible Tracheostomy Tube Cuffless Disposable Inner Cannula
Covidien LP
6UN75A
In Commercial Distribution

  • 10884521175723 ()
  • 20884521175720 ()

  • Angle: 95 degree
  • Outer Diameter: 10.8 Millimeter
  • Inner Cannula Inner Diameter,6.5,mm;Tube Inner Diameter,7.5,mm;Inner Cannula ID,6.5,mm;Proximal Length 2 (C),74,mm;Proximal Length 3 (D),35,mm;Proximal Length 4 (E),53,mm


  • Tracheostomy tube, non-reinforced, non-customized, single-use
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