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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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SPROTTE® 2.G - 14048223022808

SPROTTE® 2.G Standard Sprotte Needle 2nd generation 27G x 3 1/2" (90mm) with Introducer
Pajunk GmbH Medizintechnologie
121251-27A
Not in Commercial Distribution

  • 14048223022808 ()
  • 04048223022801 ()
121251-27A

  • Spinal needle, single-use

SATO Wire Speculum(G) - 00883475954333

No Description
CHARMANT INC.
37-0085
In Commercial Distribution

  • 00883475954333 ()


  • Eyelid speculum, reusable

Caliper with Handle(G) - 00883475952988

No Description
CHARMANT INC.
37-0064
In Commercial Distribution

  • 00883475952988 ()


  • Corneal marker, reusable

FlexiMarc G/T™ - 00853730006121

Implanted Marker in Needle
CORTEX MANUFACTURING INC.
FM-1.2-2-20-GT-17-20
In Commercial Distribution

  • 00853730006121 ()


  • Brachytherapy injection needle
  • Radiological image marker, implantable

FlexiMarc G/T™ - 00853730006114

Implanted Marker in Needle
CORTEX MANUFACTURING INC.
FM-1.2-2-10-GT-17-20
In Commercial Distribution

  • 00853730006114 ()


  • Brachytherapy injection needle
  • Radiological image marker, implantable

FlexiMarc G/T™ - 00853730006107

Implanted Marker in Needle
CORTEX MANUFACTURING INC.
FM-1.0-2-20-GT-18-20
In Commercial Distribution

  • 00853730006107 ()


  • Brachytherapy injection needle
  • Radiological image marker, implantable

FlexiMarc G/T™ - 00853730006091

Implanted Marker in Needle
CORTEX MANUFACTURING INC.
FM-1.0-2-10-GT-18-20
In Commercial Distribution

  • 00853730006091 ()


  • Brachytherapy injection needle
  • Radiological image marker, implantable

Stealth Simplicity G Cushion - 00606509700009

A padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair. It may be used to improve posture, provide back and/or side support, compensate for seat height, relieve stress points, and provide pressure alleviation for the buttocks, lumbar region, and the legs, and/or to provide an antislip mechanism. The device is typically situated behind the lower lumbar region of the back or under the buttocks and/or legs while the occupant is seated. This is a reusable device.
Pride Mobility Products Corp
Stealth Simplicity G Cushion
In Commercial Distribution

  • 00606509700009 ()
N/A

  • Wheelchair seat cushion

Barkey plasmatherm C&G - 04059201002135

Thawing and warming device for HPC, blood products, IV solution
Barkey GmbH & Co. KG
US-C&G 2.Gen
In Commercial Distribution

  • 04059201002135 ()
00010340

  • Cryopreserved blood/tissue thawing unit

Barkey plasmatherm C&G - 04059201001817

Thawing and warming device for frozen plasma (FFP, PF24 ,AHF), Whole Blood, RBC and IV solution
Barkey GmbH & Co. KG
US-C&G
In Commercial Distribution

  • 04059201001817 ()
00003475

  • Cryopreserved blood/tissue thawing unit
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