Home GUDID 00850048576056 Intacs Vacuum Centering Guide
Primary DI 00850048576056
Brand Intacs Vacuum Centering Guide
Company ADDITION TECHNOLOGY, INC.
Model KV10478-2
Device description 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.
Published 2023-06-13
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name HNH Ring, Ophthalmic (Flieringa)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HNH Ring, Ophthalmic (Flieringa) Ophthalmic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850048576056 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850048576056 00850048576056 850048576056 0850048576056
GMDN Terms# Term, Definition table Term Definition Eyeball fixation instrument, reusable A hand-held, manual, ophthalmic surgical instrument intended to be used for fixation of the eyeball during a variety of ocular procedures. The distal end is configured as an open or closed ring with a fixed or swivelling attachment to a handle; the ring may be smooth or have blunt teeth. The instrument is typically metallic. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 118496814 Device count 1 Premarket exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850048576001 Intacs Corneal Separator, CW, 0.9mm KV10730-1 2023-06-13 00850048576018 Intacs Corneal Separator, CCW, 0.9mm KV10730-2 2023-06-13 00850048576025 Intacs Inspection Gauge KV10732 2023-06-13 00850048576032 Intacs Procedure Marker KV10733 2023-06-13 00850048576049 Intacs Forceps KV10445 2023-06-13 00850048576063 Intacs Pocketing Hook KV10606 2023-06-13 00850048576070 Intacs Symmetric Glide KV1160 2023-06-13 00850048576100 Intacs for Keratoconus, Symmetric 0.210 mm ICI-210-150 11600-210-150 2023-06-13 00850048576117 Intacs for Keratoconus, Symmetric 0.250 mm ICI-250-150 11600-250-150 2023-06-13 00850048576124 Intacs for Keratoconus, Symmetric 0.300 mm ICI-300-150 11600-300-150 2023-06-13 00850048576131 Intacs for Keratoconus, Symmetric 0.350 mm ICI-350-150 11600-350-150 2023-06-13 00850048576148 Intacs for Keratoconus, Symmetric 0.400 mm ICI-400-150 11600-400-150 2023-06-13 00850048576155 Intacs for Keratoconus, Symmetric 0.450 mm ICI-450-150 11600-450-150 2023-06-13 00850048576162 Intacs for Keratoconus, Asymmetric 0.210/0.350 mm ICIA-210/350-150 11400-210/350-150 2023-06-13 00850048576179 Intacs for Keratoconus, Asymmetric 0.210/0.400 mm ICIA-210/400-150 11400-210/400-150 2023-06-13 00850048576186 Intacs for Keratoconus, Asymmetric 0.210/0.450 mm ICIA-210/450-150 11400-210/450-150 2023-06-13 00850048576193 Intacs for Myopia, Symmetric 0.250 mm ICI-250-150 11700-250-150 2023-06-13 00850048576209 Intacs for Myopia, Symmetric 0.300 mm ICI-300-150 11700-300-150 2023-06-13 00850048576216 Intacs for Myopia, Symmetric 0.350 mm ICI-350-150 11700-350-150 2023-06-13 00866304000142 Intacs Sterile Vacuum Tubing 7K6000 2023-06-13
Other Devices Sharing Product Codes#