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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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EMED Soluble Hemostatic Gauze
EMED TECHNOLOGIES CORPORATION
EHEM42-1
Not in Commercial Distribution

  • 00817708022940 ()
  • 00817708022933 ()
EHEM42-1

  • Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial
CUSA® Clarity 36kHz Standard Tip
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7412SEA
In Commercial Distribution

  • 10381780251316 ()
C7412SEA

  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
CUSA® Clarity 36kHz Standard Tip
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7412S
In Commercial Distribution

  • 30381780251303 ()
  • 10381780251309 ()
C7412S

  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
The extended life laparoscopic tip is intended for use with the CUSA® Excel/ CUSA® Excel+ Ultrasonic Surgical Aspirator System, CUSA® Handpiece and accessories. The CUSA Excel System is indicated for use in these surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable: • Neurosurgery • Gastrointestinal and affiliated organ surgery • Urological surgery • Plastic and reconstructive surgery • General surgery • Orthopedic surgery • Gynecological surgery • Thoracic surgery • Laparoscopic surgery • Thoracoscopic surgery
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C4604ELTUS
In Commercial Distribution

  • 30381780248242 ()
  • 10381780248248 ()
  • M269C4604ELTUS1 ()

  • Length 30.14 cm; Diameter 1.98mm


  • Soft-tissue ultrasonic surgical system handpiece tip, reusable
JUMPSTART, 4" X 4", HELIX COMP. LAYER
ARTHREX, INC.
HR0404-05
In Commercial Distribution

  • 00888867186590 ()
  • M150HR0404050 ()
  • 10888867186597 ()
HR0404-05

  • Exudate-absorbent dressing, non-gel, antimicrobial
JumpStart, 1.5" X 10", Single Layer
ARTHREX, INC.
R1510-10
In Commercial Distribution

  • 00888867186576 ()
  • M150R1510100 ()
  • 10888867186573 ()
R1510-10

  • Exudate-absorbent dressing, non-gel, antimicrobial
The Proximal Phalanx Total Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL89040PPT
In Commercial Distribution

  • M269TRL89040PPT1 ()
  • 10381780236955 ()

  • Size 40; .771 in L x .549 in W (head); .472 in L (stem)


  • Surgical implant template, reusable
The Proximal Phalanx Total Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL89030PPT
In Commercial Distribution

  • M269TRL89030PPT1 ()
  • 10381780236924 ()

  • Size 30; .721 in L x .520 in W (head); .433 in L (stem)


  • Surgical implant template, reusable
The Proximal Phalanx Total Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL89020PPT
In Commercial Distribution

  • M269TRL89020PPT1 ()
  • 10381780236894 ()

  • Size 20; .66 in L x .493 in W (head); .394 in L (stem)


  • Surgical implant template, reusable
The Proximal Phalanx Total Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL89010PPT
In Commercial Distribution

  • M269TRL89010PPT1 ()
  • 10381780236863 ()

  • Size 10; .606 in L x .463 in W (head); .354 in L (stem)


  • Surgical implant template, reusable
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