Home GUDID 00850048576063 Intacs Pocketing Hook
Primary DI 00850048576063
Brand Intacs Pocketing Hook
Company ADDITION TECHNOLOGY, INC.
Model KV10606
Device description Designed to be used in an operating room environment by a surgeon to delaminate cornea stroma to initiate a pocket on each side of the incision.
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 HNG Rongeur, Lachrymal Sac
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HNG Rongeur, Lachrymal Sac Ophthalmic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850048576063 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 00850048576063 00850048576063 850048576063 0850048576063
GMDN Terms# Term, Definition table Term Definition Ophthalmic surgical probe, reusable A slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. 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 00850048576056 Intacs Vacuum Centering Guide KV10478-2 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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