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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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IMPIX 3D Print - 03613720272588

IB3D TO (C) 10 x 06° x 24 x 10
MEDICREA INTERNATIONAL
B247C10062410
Not in Commercial Distribution

  • 03613720272588 ()


  • Metallic spinal interbody fusion cage

IMPIX 3D Print - 03613720272557

IB3D TO (C) 09 x 06° x 24 x 10
MEDICREA INTERNATIONAL
B247C09062410
Not in Commercial Distribution

  • 03613720272557 ()


  • Metallic spinal interbody fusion cage

IMPIX 3D Print - 03613720272533

IB3D TO (C) 08 x 06° x 24 x 10
MEDICREA INTERNATIONAL
B247C08062410
Not in Commercial Distribution

  • 03613720272533 ()


  • Metallic spinal interbody fusion cage

ABS Spike Adapter - 10816203021974

Spike extender set, resistant to 80% DMSO, case of 24
ORIGEN BIOMEDICAL, INC.
ST-A
Not in Commercial Distribution

  • 10816203021974 ()
  • 20816203021971 ()


  • Blood transfer set

SMR System - 08033390274555

SMR System - Humeral Head Dia. 54 mm H. 24 mm
LIMACORPORATE SPA
1325.09.541
In Commercial Distribution

  • 08033390274555 ()

  • Dia. 54 mm H. 24 mm
1325.09.541

  • Stem-fixed metallic humeral head prosthesis

SMR System - 08033390270878

SMR System - Finned Stem Dia. 24 mm L. 80 mm
LIMACORPORATE SPA
1304.15.240
In Commercial Distribution

  • 08033390270878 ()

  • Dia. 24 mm L. 80 mm
1304.15.240

  • Press-fit shoulder humeral stem prosthesis

TECOFLEX - 00821925006409

6.0FR(2mm) X 24 cm DOUBLE PIGTAIL URETERAL STENT TECOFLEX
Gyrus ACMI, LLC
5616024
In Commercial Distribution

  • 00821925006409 ()


  • Polymeric ureteral stent

TECOFLEX - 00821925006027

8.5FR(2.81mm) X 24 cm DOUBLE PIGTAIL URETERAL STENT TECOFLEX
Gyrus ACMI, LLC
5618524
In Commercial Distribution

  • 00821925006027 ()


  • Polymeric ureteral stent

TECOFLEX - 00821925005235

4.5FR(1.49mm) X 24 cm DOUBLE PIGTAIL URETERAL STENT TECOFLEX
Gyrus ACMI, LLC
5614524
In Commercial Distribution

  • 00821925005235 ()


  • Polymeric ureteral stent

TECOFLEX - 00821925005150

7.0FR(2.3mm) X 24 cm DOUBLE PIGTAIL URETERAL STENT TECOFLEX
Gyrus ACMI, LLC
5617024
In Commercial Distribution

  • 00821925005150 ()


  • Polymeric ureteral stent
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