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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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PERCLOSE - 08717648013065

PERCLOSE A-T 6F Suture-Medicated Closure System
ABBOTT VASCULAR INC.
12337-04
Not in Commercial Distribution

  • 28717648013069 ()
  • 08717648013065 ()
12337-04

  • Femoral vessel suture implantation set

CUSTOM - 03613720275725

IB3D TB trial 10mm at 6°
MEDICREA INTERNATIONAL
A99181110
Not in Commercial Distribution

  • 03613720275725 ()


  • Spinal implant trial

2100 3 WAY STOPCOCK - 00817136022673

2100A W/ C PORT AT 180
HANS RUDOLPH, INC.
2100
Not in Commercial Distribution

  • 00817136022673 ()
C147

  • Pulmonary function valve

PC - 00026072021095

REG O2 PRE-SET AT 50 PSI
Allied Medical, LLC
32-10-0309
In Commercial Distribution

  • 00026072021095 ()


  • Non-fixed medical gas cylinder regulator

Sklar® - 10649111386770

GERALD AT TISSUE FCP 1.2MM STR
SKLAR CORPORATION
47-119
In Commercial Distribution

  • 10649111386770 ()


  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

Sklar® - 10649111386787

GERALD AT TISSUE FCP 1.2MM STR
SKLAR CORPORATION
47-1197
In Commercial Distribution

  • 10649111386787 ()


  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

IMPIX TLIF - 03613720193715

IMPIX-TLIF LUMBAR CAGE 7mm at 6°
MEDICREA INTERNATIONAL
B15130607
Not in Commercial Distribution

  • 03613720193715 ()
B15130607

  • Polymeric spinal interbody fusion cage

CUSTOM - 03613720275770

IB3D TB trial 15mm at 6°
MEDICREA INTERNATIONAL
A99181115
Not in Commercial Distribution

  • 03613720275770 ()
A99181115

  • Orthopaedic surgical procedure kit, non-medicated, reusable

CUSTOM - 03613720275763

IB3D TB trial 14mm at 6°
MEDICREA INTERNATIONAL
A99181114
Not in Commercial Distribution

  • 03613720275763 ()
A99181114

  • Orthopaedic surgical procedure kit, non-medicated, reusable

CUSTOM - 03613720275756

IB3D TB trial 13mm at 6°
MEDICREA INTERNATIONAL
A99181113
Not in Commercial Distribution

  • 03613720275756 ()
A99181113

  • Orthopaedic surgical procedure kit, non-medicated, reusable
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