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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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The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal head dorsally. The implant is fixed by means of a stem, which is inserted into the metatarsal intramedullary canal. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012002
Not in Commercial Distribution

  • M2480120021 ()
  • 10381780065395 ()

  • .85 in L x .696 in W; Size 1
012002

  • Partial metatarsophalangeal joint prosthesis
Surgaflex™ is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Surgaflex™ is intended for the management of wounds. The device is packaged in sterile, sealed box of 5.
IMBED BIOSCIENCES, INC.
91018
In Commercial Distribution

  • 00850019162295 ()


  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
The KKT-M2 device is to be used in the aid of management of chronic pain due to non-congenital defects. The device can be used as part of a series of steps in the total care of the patient. The procedure involves the use of diagnostic imaging that qualifies the misalignment between vertebrae. The treatment is then administered using the KKT-M2 device to deliver precise impulses at a required vector configuration.
Optima Health Solutions International Corporation
KKT-M2
In Commercial Distribution

  • B854M20 ()
M2

  • Physical therapy ultrasound system
The T.O.V.A. microswitch precisely and accurately measures a subject's responses to the Test of Variables of Attention (T.O.V.A.), a computerized assessment of attention and inhibitory control. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
TOVA COMPANY, THE
Microswitch
In Commercial Distribution

  • 00862290000319 ()


  • Cognitive assessment software
Salvin OraTAPE Resorbable Collagen Wound Dressing - Package of 10
SALVIN DENTAL SPECIALTIES, LLC
ORATAPE-PKG-10
In Commercial Distribution

  • 00841336100893 ()
  • 10841336100890 ()

  • Width: 25 Millimeter
  • Length: 75 Millimeter
ORATAPE-PKG-10

  • General oral wound dressing, animal-derived
Simplee® Retraction Paste (Lifco) (Pkg. of 30 Capsules)
PARKELL, INC.
156215
In Commercial Distribution

  • 00810000525713 ()
  • 10810000525710 ()
156215

  • Gingival retraction cord, non-medicated
Parkell® Universal Ground Clip (Pkg. of 2 pcs.)
PARKELL, INC.
D619GC
In Commercial Distribution

  • 10810000520241 ()
  • 00810000520244 ()
D619GC

  • Endodontic apex locator
ER20XS-SMF-C 4 pack of ER20XS for PriceSmart Part# 20196
ETYMOTIC RESEARCH, INC.
ER20XS-SMF-C
In Commercial Distribution

  • 00846430005990 ()


  • Earplugs, reusable
Package of 1 disc 95mmX20mm Zirkonzahn/Clover Leaf Edge
ASTRON DENTAL CORPORATION
PCSD95
In Commercial Distribution

  • D810PCSD2095Z111 ()
PCSD95

  • Mouthguard, single-use
CUSA® Selector® 35KHzStandard Flue (Pack of 20)
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523043
Not in Commercial Distribution

  • M27315230431 ()
  • 10381780040675 ()
  • 00381780040678 ()

  • 35kHz Ultrasonic Frequency
1523043

  • Ultrasonic surgical system flue
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