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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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Audio Processor Accessory
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38301
In Commercial Distribution

  • 09008737383015 ()


  • Cochlear implant system external kit
FebriDx® Bacterial / Non-Bacterial Point of Care Assay, External Controls Kit
Lumos Diagnostics, Inc.
CP0007
In Commercial Distribution

  • 00850056728409 ()
CP0007

  • Multiple-type clinical chemistry analyte profile IVD, control
Wylie external carotid clamp, 8", curved/straight, atraumatic jaws, ring handle
AMBLER SURGICAL CORP.
17-782
In Commercial Distribution

  • 00190660018351 ()
17-782

  • Vascular clamp, reusable
Non-Infused Single-Use Z/pH Probe (External Reference), Dual pH (Gastric & Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZPN-BG-07E
In Commercial Distribution

  • 00816734022382 ()
  • B019ZPNBG07E0 ()

  • Catheter Gauge: 6.4 French
ZPN-BG-07E

  • Manometric gastrointestinal motility analysis system
The External Data Card is used with the Sterilization Container System.
STERIS CORPORATION
SC1167
Not in Commercial Distribution

  • 10724995002494 ()
  • 00724995002497 ()
SC1167

  • Device sterilization/disinfection container, reusable
Reusable external orthopaedic fixation system instrument intended for cutting Kirschner wires.
GEXFIX SA
5040-1000
In Commercial Distribution

  • 07640136270521 ()


  • General external orthopaedic fixation system implantation kit, reusable
Male External Catheter, Medium 29 mm, Non Latex w/ skin Wipe
The Lighthouse For The Blind
Ultra Flex Medium w/ wipes
In Commercial Distribution

  • 00009235421819 ()
2204039

  • Urinary incontinence penis sheath/port, single-use
MediChoice® Suction Canister Filter Reusable External Shut-Off Valve 1 Each
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411005996 ()
  • 30704411005999 ()
  • 10704411005995 ()
WFM01FLT

  • Suction system canister liner
IV Rod & Holder f/2" Post, External Mount (requires 2" Post)
Medical Technology Industries, Inc.
7000008
In Commercial Distribution

  • 10840118415078 ()
7000008

  • Freestanding/bed-attached intravenous pole
Male External Catheter,Standard One Piece Sheath Design with Foam Strap
Cardinal Health, Inc.
8884732300
Not in Commercial Distribution

  • 20884521004167 ()
  • 10884521004160 ()

  • Outer Diameter: 1.375 Inch
8884732300

  • Indwelling urethral catheterization kit, adult
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