Home GUDID 00850048576025 Intacs Inspection Gauge
Primary DI 00850048576025
Brand Intacs Inspection Gauge
Company ADDITION TECHNOLOGY, INC.
Model KV10732
Device description 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.
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 HND Spatula, Ophthalmic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HND Spatula, Ophthalmic Ophthalmic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850048576025 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 00850048576025 00850048576025 850048576025 0850048576025
GMDN Terms# Term, Definition table Term Definition General-purpose surgical spatula A hand-held manual surgical instrument designed to manipulate tissue during various types of surgical interventions. It typically consists of a flat blunt blade (no sharp edges) that is double-ended (a blade at either end) and is not constructed for one particular part of the anatomy or clinical specialty. It is usually made of high-grade stainless steel and is available with a variety of blade designs, e.g., curved and flat or straight and flat with rounded ends; some blade types may be more right-angled. The handle will be formed from its middle section and may be more prominent/serrated. 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 00850048576032 Intacs Procedure Marker KV10733 2023-06-13 00850048576049 Intacs Forceps KV10445 2023-06-13 00850048576056 Intacs Vacuum Centering Guide KV10478-2 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
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