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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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Shell Assembly Tall 27mm Version B
Integrity Implants Inc.
II-1-0173
Not in Commercial Distribution

  • 00850231007473 ()
FHTA-CT-00-27-B

  • Polymeric spinal interbody fusion cage
Shell Assembly Short 27mm Version B
Integrity Implants Inc.
II-1-0172
Not in Commercial Distribution

  • 00850231007466 ()
FHTA-CS-00-27-B

  • Metallic spinal interbody fusion cage
KIT C SEC PART B HILLCREST
MEDLINE INDUSTRIES, INC.
DYNJ907624A
In Commercial Distribution

  • 10195327095413 ()
DYNJ907624A

  • General surgical procedure kit, non-medicated, single-use
KIT C SEC PART B SOUTHCREST
MEDLINE INDUSTRIES, INC.
DYNJ907644A
In Commercial Distribution

  • 10195327093112 ()
DYNJ907644A

  • General surgical procedure kit, non-medicated, single-use
SomnoDent AVANT with Strap Kit B
SOMNOMED, INC.
SomnoDent AVANT with Strap Kit B
In Commercial Distribution

  • 00851826007298 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
CIRC ANESTH PED 2 B/V-LF
MEDLINE INDUSTRIES, INC.
DYNJAP10073
In Commercial Distribution

  • 40195327137015 ()
  • 10195327137014 ()
DYNJAP10073

  • General surgical procedure kit, non-medicated, single-use
SM OPEN HEART PACK A&B
MEDLINE INDUSTRIES, INC.
DYNJ904749B
In Commercial Distribution

  • 10889942886999 ()
DYNJ904749B

  • General surgical procedure kit, medicated
GEMINI STRAP SYSTEM,B,LOOP LOK
MORRISON MEDICAL, LTD
1383B-L
In Commercial Distribution

  • 00647921138322 ()
1383B-L

  • Limb/torso/head restraint, reusable
E8089 Crea B electrode for ABL8XX
Radiometer Medical ApS
945-663
In Commercial Distribution

  • 05700699456632 ()
945-663

  • Creatinine IVD, reagent
B. burgdorferi WB Negative Control, 120µL
MARDX DIAGNOSTICS, INC.
40-2021L
In Commercial Distribution

  • 05391516747615 ()
40-2021L

  • Borrelia burgdorferi antigen IVD, control
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