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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 Vacuum Centering Guide (VCG) is composed of stainless steel and features a port for attachment to a vacuum source (KV2000 Vacuum System). The VCG functions as a suction ring that is equipped with fins on the bottom to provide for rotational stability and a seating surface for adherence to and stabilization of the eye during the creation of the intrastromal tunnels. The VCG is contoured to allow for a more natural fit under the eye lids and the speculum.
ADDITION TECHNOLOGY, INC.
KV10478-2
In Commercial Distribution

  • 00850048576056 ()


  • Eyeball fixation instrument, reusable
Designed to be used in an operating room environment by a surgeon to secure hold and facilitate placement of the INTACS implant.
ADDITION TECHNOLOGY, INC.
KV10445
In Commercial Distribution

  • 00850048576049 ()


  • Dressing/utility forceps, scissors-like, reusable
The Procedure Marker, 0.9 mm is used for marking the 1.2 mm incision and the placement marks for the 150 degree Intacs® Corneal Implants by aligning the reticle with the center mark that has been created on the cornea. This multi-functional device is also used later in the surgical procedure to align the Vacuum Centering Guide on the cornea.
ADDITION TECHNOLOGY, INC.
KV10733
In Commercial Distribution

  • 00850048576032 ()


  • Corneal marker, reusable
The Inspection Gauge, 0.9 mm is used as a reference to inspect the concentricity and planarity of the 0.9 mm CW and CCW Corneal Separators prior to each Intacs Corneal Implants surgery.
ADDITION TECHNOLOGY, INC.
KV10732
In Commercial Distribution

  • 00850048576025 ()


  • General-purpose surgical spatula
The Corneal Separators are composed of a stainless-steel tubular body with a 210° blade attached to the body by a spoke. Each Corneal Separator is inserted through the 0.9 mm entry incision to create either a CW or a CCW annular subsurface tunnel. The Corneal Separators are designed for use with the Vacuum Centering Guide (VCG). Each Corneal Separator is designed to slide easily into the VCG and to rotate smoothly through the stroma to precisely create the CW and CCW intrastromal tunnels within the cornea.
ADDITION TECHNOLOGY, INC.
KV10730-2
In Commercial Distribution

  • 00850048576018 ()


  • General-purpose surgical spatula
The Corneal Separators are composed of a stainless-steel tubular body with a 210° blade attached to the body by a spoke. Each Corneal Separator is inserted through the 0.9 mm entry incision to create either a CW or a CCW annular subsurface tunnel. The Corneal Separators are designed for use with the Vacuum Centering Guide (VCG). Each Corneal Separator is designed to slide easily into the VCG and to rotate smoothly through the stroma to precisely create the CW and CCW intrastromal tunnels within the cornea.
ADDITION TECHNOLOGY, INC.
KV10730-1
In Commercial Distribution

  • 00850048576001 ()


  • General-purpose surgical spatula
Dentistry Lock Pad 7" x 5.5"
Medicalock Corporation
Dentistry Lock Pad
In Commercial Distribution

  • 00850047863133 ()
  • 00850047863140 ()
DLP0755

  • Instrument tray, reusable
Multi-Link™ X2 ECG Reusable Trunk Cable 3-Lead for Nihon Kohden, IEC, 3,6 m/ 12 ft
AirLife Finland Oy
2090200-082
In Commercial Distribution

2090200-082

  • Electrocardiographic lead set, reusable
Multi-Link™ X2 ECG Reusable Trunk Cable 3-Lead for Nihon Kohden, IEC, 23 cm/ 9 in
AirLife Finland Oy
2090200-081
In Commercial Distribution

2090200-081

  • Electrocardiographic lead set, reusable
Multi-Link™ X2 ECG Reusable Trunk Cable 3-Lead for Spacelabs, IEC, 23 cm/ 9 in
AirLife Finland Oy
2090200-077
In Commercial Distribution

2090200-077

  • Electrocardiographic lead set, reusable
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