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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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MCT 5 change trolley, 700 x 1900 mm, two fold-down sides, white. Manually height adjustable with foot pedal
Pressalit A/S
R95027
In Commercial Distribution

  • 05708590389875 ()
R9502719000

  • Bathing/changing table, mobile
MCT 5 change trolley, 700 x 1700 mm, two fold-down sides, white. Manually height adjustable with foot pedal
Pressalit A/S
R95027
In Commercial Distribution

  • 05708590389868 ()
R9502717000

  • Bathing/changing table, mobile
No Description
Axiodent Inc.
21002 Economy Pack
In Commercial Distribution

  • D161210020 ()


  • Dental acrylic resin kit
No Description
Axiodent Inc.
21001 Intro Pack
In Commercial Distribution

  • D161210010 ()


  • Dental acrylic resin kit
The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a solution of up to 1.0% cobalt chloride and up to 2.0% N-Acetyl cysteine, in a ratio of 1:2. Zirconium oxide is sealed within the device. The length of the polymer capsule is between 5.5 mm and 10.0 mm, and the diameter is 1.0 mm. It is loaded in an implant needle and sterilized with Ethylene Oxide.
C4 IMAGING, LLC
F-01-03-0111
In Commercial Distribution

  • 00863593000259 ()


  • Radiological image marker, implantable
The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a solution of up to 1.0% cobalt chloride and up to 2.0% N-Acetyl cysteine, in a ratio of 1:2. Zirconium oxide is sealed within the device. The length of the polymer capsule is between 5.5 mm and 10.0 mm, and the diameter is between 0.9 mm and 1.2 mm.
C4 IMAGING, LLC
F-01-03-0011
In Commercial Distribution

  • 00863593000242 ()


  • Radiological image marker, implantable
The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries. System includes one TST-11 tip.
3shape Trios A/S
L1P-1F
In Commercial Distribution

  • 05902729754149 ()


  • Intraoral optical scanning system
No Description
3shape Trios A/S
L1-2
In Commercial Distribution

  • 05902729753739 ()


  • Intraoral optical scanning system
The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries. System includes five TST-11 tips.
3shape Trios A/S
L1P-1F
In Commercial Distribution

  • 05902729753722 ()


  • Intraoral optical scanning system
FREESTYLE 5 PORTABLE OXYGEN CONCENTRATOR, 1-5LPM, REFURBISHED
CAIRE INC.
AS077-1U
In Commercial Distribution

  • M766AS0771U0 ()


  • Mobile/portable oxygen concentrator
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