Home GUDID 10850394006051
Inlay Inserter Chuck Handle
Primary DI 10850394006051
Brand Inlay Inserter Chuck Handle
Company REVISION OPTICS, INC.
Model 607-0002
Catalog number 607-0002
Device description The Inlay Inserter Chuck Handle is used in conjunction with the Inlay Inserter to extend the length of the device for ease of use while delivering the Raindrop® Near Vision Inlay. The Inserter Handle has three components: the handle, the sleeve, and the chuck.
Published 2016-08-19
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Product Codes# Code, Name table Code Name LQE Implant, Corneal, Refractive
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LQE Implant, Corneal, Refractive Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10850394006051 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10850394006051 10850394006051
GMDN Terms# Term, Definition table Term Definition Ophthalmic surgical instrument handle, manual, reusable A hand-held manual device designed to hold and operate a compatible ophthalmic surgical instrument tip (typically scissors, forceps). It is typically in the form of a conventional handle with a connector that secures the inserted tip, and has a manually-operated internal actuating piston that operates the inserted tip (e.g., opens and closes blades). It is typically used for surgery in the anterior or the posterior segment to cut, grasp, and manipulate eye tissue; it is not a handle for a corneal trephine. This is a reusable device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 In between use, store the packaged instrument in a dry and clean environment.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 015504442 Device count 1 Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10850394006013 Raindrop Near Vision Inlay RD1-1 RD1-1 2016-08-19
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850048576100 Intacs for Keratoconus, Symmetric 0.210 mm ADDITION TECHNOLOGY, INC. LQE 2023-06-13 00850048576117 Intacs for Keratoconus, Symmetric 0.250 mm ADDITION TECHNOLOGY, INC. LQE 2023-06-13 00850048576124 Intacs for Keratoconus, Symmetric 0.300 mm ADDITION TECHNOLOGY, INC. LQE 2023-06-13 00850048576131 Intacs for Keratoconus, Symmetric 0.350 mm ADDITION TECHNOLOGY, INC. LQE 2023-06-13 00850048576148 Intacs for Keratoconus, Symmetric 0.400 mm ADDITION TECHNOLOGY, INC. LQE 2023-06-13 00850048576155 Intacs for Keratoconus, Symmetric 0.450 mm ADDITION TECHNOLOGY, INC. LQE 2023-06-13 00850048576162 Intacs for Keratoconus, Asymmetric 0.210/0.350 mm ADDITION TECHNOLOGY, INC. LQE 2023-06-13 00850048576179 Intacs for Keratoconus, Asymmetric 0.210/0.400 mm ADDITION TECHNOLOGY, INC. LQE 2023-06-13 00850048576186 Intacs for Keratoconus, Asymmetric 0.210/0.450 mm ADDITION TECHNOLOGY, INC. LQE 2023-06-13 00850048576193 Intacs for Myopia, Symmetric 0.250 mm ADDITION TECHNOLOGY, INC. LQE 2023-06-13 00850048576209 Intacs for Myopia, Symmetric 0.300 mm ADDITION TECHNOLOGY, INC. LQE 2023-06-13 00850048576216 Intacs for Myopia, Symmetric 0.350 mm ADDITION TECHNOLOGY, INC. LQE 2023-06-13 00813359020052 KAMRA inlay Bausch & Lomb Incorporated LQE 2017-01-13 00813359020045 KAMRA inlay Bausch & Lomb Incorporated LQE 2017-01-05 10850394006013 Raindrop Near Vision Inlay REVISION OPTICS, INC. LQE 2016-08-19 00866304000104 Intacs Corneal Implants ADDITION TECHNOLOGY, INC. LQE 2015-06-30 00813359020007 KAMRA inlay Bausch & Lomb Incorporated LQE 2015-04-29