FDA.reportPublic FDA data

Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear

Primary DI
85000713500102
Brand
Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear
Company
EUCLID SYSTEMS CORPORATION
Model
Emerald
Device description
Emerald, oprifocon A, Blue
Published
2019-07-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
85000713500003PackageGS11In Commercial Distribution
85000713500102PackageGS11In Commercial Distribution
00850007135003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
8500071350000385000713500003
8500071350010285000713500102
00850007135003008500071350038500071350030850007135003

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

Contacts#

Phone, Email table
PhoneEmail
1-(800) 477-9396UDI@euclidsys.com

Regulatory Flags#

DUNS number
969263979
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
85000713599977Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEmerald Toric2020-03-02
85000713599960Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEmerald Toric2020-03-02
85000713599991Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEmerald2020-02-29
85000713599984Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEmerald2020-02-29
85000713500119Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEmerald2019-07-19
85000713500126Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEmerald2019-07-19
85000713500133Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEmerald2019-07-19
85000713500140Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight WearEmerald2019-07-19
85000713500157Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEmerald Toric2019-07-19
85000713500164Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEmerald Toric2019-07-19
85000713500171Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEmerald Toric2019-07-19
85000713500188Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight WearEmerald Toric2019-07-19
85000713500195Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight WearEmerald Toric2019-07-19

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
10840162099989Euclid 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