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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LQEImplant, Corneal, Refractive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQEImplant, Corneal, RefractiveUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150034000Raindrop Near Vision InlayRvo 2.0, Inc. (D.B.A. Optics Medical)2016-06-29LQE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850394006051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085039400605110850394006051

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical instrument handle, manual, reusableA 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
TypeLowHighCondition
Special Storage Condition, Specify00In between use, store the packaged instrument in a dry and clean environment.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
949-707-2740customerservice@revisionoptics.com

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 DIBrandModelCatalogPublished
10850394006013Raindrop Near Vision InlayRD1-1RD1-12016-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850048576100Intacs for Keratoconus, Symmetric 0.210 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576117Intacs for Keratoconus, Symmetric 0.250 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576124Intacs for Keratoconus, Symmetric 0.300 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576131Intacs for Keratoconus, Symmetric 0.350 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576148Intacs for Keratoconus, Symmetric 0.400 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576155Intacs for Keratoconus, Symmetric 0.450 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576162Intacs for Keratoconus, Asymmetric 0.210/0.350 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576179Intacs for Keratoconus, Asymmetric 0.210/0.400 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576186Intacs for Keratoconus, Asymmetric 0.210/0.450 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576193Intacs for Myopia, Symmetric 0.250 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576209Intacs for Myopia, Symmetric 0.300 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576216Intacs for Myopia, Symmetric 0.350 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00813359020052KAMRA inlayBausch & Lomb IncorporatedLQE2017-01-13
00813359020045KAMRA inlayBausch & Lomb IncorporatedLQE2017-01-05
10850394006013Raindrop Near Vision InlayREVISION OPTICS, INC.LQE2016-08-19
00866304000104Intacs Corneal ImplantsADDITION TECHNOLOGY, INC.LQE2015-06-30
00813359020007KAMRA inlayBausch & Lomb IncorporatedLQE2015-04-29