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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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INFINTY EXTERNAL HEX SYSTEM - 00614950027774

MULTI-UNIT DRIVER
ACE SURGICAL SUPPLY CO., INC.
MU0028
In Commercial Distribution

  • 00614950027774 ()
MU0028

  • Dental implant suprastructure, permanent, preformed

CirFIX® Cranial bone fixation system: Burr Hole Cover - 04717002404335

CUSMED CirFIX® Burr Hole Cover, Radiolucent Revisable Type for Shunt & ICP+Screwdriver, PEEK, 14mm/11mm, Sterile
OSSAWARE BIOTECH CO., LTD.
9906.0014.11S
In Commercial Distribution

  • 04717002404335 ()
  • 14717002404332 ()
  • 24717002404339 ()
9906.0014.11S

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

CirFIX® Cranial bone fixation system: Burr Hole Cover - 04717002404328

CUSMED CirFIX® Burr Hole Cover, Radiolucent Revisable Type+Screwdriver, PEEK, 14mm/11mm, Sterile
OSSAWARE BIOTECH CO., LTD.
9905.0014.11S
In Commercial Distribution

  • 14717002404325 ()
  • 04717002404328 ()
  • 24717002404322 ()
9905.0014.11S

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

Teeth Screw Driver - 04719872108795

A mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral surgical intervention.
ENTER MEDICAL CORPORATION
PN-2002
In Commercial Distribution

  • 04719872108795 ()


  • Mouth gag, non-adjustable

DUAL SHOT alpha 7 - 04560138481707

Nemoto DUAL SHOT alpha 7 contrast delivery system for CT applications.
NEMOTO KYORINDO CO.,LTD.
170
In Commercial Distribution

  • 04560138481707 ()
  • 14560138481704 ()


  • CT contrast medium injection system, line-powered, mobile

SONIC SHOT GX - 04560138480700

Nemoto SONIC SHOT GX contrast delivery system for MRI applications.
NEMOTO KYORINDO CO.,LTD.
070
In Commercial Distribution

  • 14560138480707 ()
  • 04560138480700 ()


  • MRI contrast medium injection system, line-powered, mobile

NA - 00844868018841

PROSTHETIC TORQUE DRIVER KIT
BIOMET 3I, LLC
NPSDK0
In Commercial Distribution

  • 00844868018841 ()


  • Dental implant/prosthesis surgical procedure kit

CERTAIN® - 00844868018834

CONTRA ANGLE TORQUE DRIVER KIT CERTAIN®
BIOMET 3I, LLC
NCATD0C
In Commercial Distribution

  • 00844868018834 ()


  • Dental implant/prosthesis surgical procedure kit

NA - 00844868018827

CONTRA ANGLE TORQUE DRIVER KIT
BIOMET 3I, LLC
NCATD0
In Commercial Distribution

  • 00844868018827 ()


  • Dental implant/prosthesis surgical procedure kit

NAVIGATOR® - 00844868016120

NAVIGATOR® LABORATORY KIT
BIOMET 3I, LLC
SGLKIT
In Commercial Distribution

  • 00844868016120 ()


  • Surgical screwdriver, reusable
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