Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear

Primary DI
10840162099989
Brand
Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear
Company
Euclid Vision Corporation
Model
CHN002-11-P1
Catalog number
Emerald Advance
Device description
Kit containing 1x 00850007135010 (Emerald Advance, oprifocon A, Green) China Distribution
Published
2026-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NUULens, Contact, Orthokeratology, Overnight

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUULens, Contact, Orthokeratology, OvernightOphthalmic3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P040029000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P040029000Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) ContactEuclid Vision Corporation2004-09-29NUU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840162099989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084016209998910840162099989

GMDN Terms#

Term, Definition table
TermDefinition
Orthokeratology contact lensA rigid-gas-permeable ophthalmic lens intended to be worn directly against the cornea of the eye for orthokeratology (Ortho-K), a procedure where the lens is worn for several hours, typically each night, to modify the curvature of the cornea as an alternative method to correct refractive vision conditions. The device is made of various materials (e.g., cellulose acetate butyrate, polyacrylate-silicone, silicone elastomers) whose main polymer molecules generally do not absorb or attract water but permit diffusion of oxygen (O2) to the ocular surface. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
969263979
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850007135003Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEmeraldEmerald 2019-07-19
00850007135010Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEmeraldEmerald2019-07-19
00850007135027Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEmeraldEmerald2019-07-19
00850007135034Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEmeraldEmerald2019-07-19
00850007135058Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEmerald ToricEmerald Toric2019-07-19
00850007135065Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEmerald ToricEmerald Toric2019-07-19
00850007135072Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEmerald ToricEmerald Toric2019-07-19
00850007135089Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEmerald ToricEmerald Toric2019-07-19
00850007135515Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearCHN001-11-P1Emerald2026-02-05
00850007135522Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearCHN001-11-P1Emerald2026-02-05
00850007135539Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearCHN010-11-P1Emerald Toric2026-02-05
00850007135546Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearCHN010-11-P1Emerald Toric2026-02-05
10840162000183Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearCHN006-11-P1Emerald Essential2026-02-05
10840162000190Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearCHN006-11-P1Emerald Essential2026-02-05
10840162000206Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearCHN008-11-P1Emerald Essential Toric2026-02-05
10840162000213Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearCHN008-11-P1Emerald Essential Toric2026-02-05
10840162000244Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearCHN002-11-P2Emerald Advance2026-02-05
10840162000251Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearCHN006-11-P2 Emerald Essential2026-02-05
10840162000268Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearCHN002-11-P2Emerald Advance2026-02-05
10840162000275Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearCHN006-11-P2 Emerald Essential2026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850007135515Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
00850007135522Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
00850007135539Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
00850007135546Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000183Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000190Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000206Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000213Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000244Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000251Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000268Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000275Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000282Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000299Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000305Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000312Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000329Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000336Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000343Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162000350Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162099965Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162099972Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10840162099996Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10850007135604Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
10850007135611Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
85000713501468Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
85000713501475Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
85000713501512Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
85000713501529Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2026-02-05
00850007135645Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight WearEuclid Vision CorporationNUU2025-08-05