Home GUDID 00850048576049 Intacs Forceps
Primary DI 00850048576049
Brand Intacs Forceps
Company ADDITION TECHNOLOGY, INC.
Model KV10445
Device description Designed to be used in an operating room environment by a surgeon to secure hold and facilitate placement of the INTACS implant.
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 HNR Forceps, Ophthalmic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HNR Forceps, Ophthalmic Ophthalmic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850048576049 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 00850048576049 00850048576049 850048576049 0850048576049
GMDN Terms# Term, Definition table Term Definition Dressing/utility forceps, scissors-like, reusable A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.
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 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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