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

GUDID 10850007135611

Kit containing 00850007135003 (Emerald, oprifocon A, Blue) and 00850007135010 (Emerald, oprifocon A, Green) China Distribution

Euclid Vision Corporation

Orthokeratology contact lens
Primary Device ID10850007135611
NIH Device Record Keycd08ca5f-7522-4346-ae57-e8d36f13ba09
Commercial Distribution StatusIn Commercial Distribution
Brand NameEuclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear
Version Model NumberCHN001-11-P2
Catalog NumberEmerald
Company DUNS969263979
Company NameEuclid Vision Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110850007135611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NUULens, Contact, Orthokeratology, Overnight

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-13
Device Publish Date2026-02-05

On-Brand Devices [Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear]

85000713500201Kit containing 850007135003 (Emerald, oprificon A, Blue) and 850007135010 (Emerald, oprifocon A,
85000713501529Kit containing 2x 00850007135065 (Emerald Toric, oprifocon A, Green) China Distribution
85000713501512Kit containing 2x 00850007135058 (Emerald Toric, oprifocon A, Blue) China Distribution
85000713501475Kit containing 2x 00850007135010 (Emerald, oprifocon A, Green) China Distribution
85000713501468Kit containing 2x 00850007135003 (Emerald, oprifocon A, Blue) China Distribution
10850007135611Kit containing 00850007135003 (Emerald, oprifocon A, Blue) and 00850007135010 (Emerald, oprifoco
10850007135604Kit containing 00850007135058 (Emerald Toric, oprifocon A, Blue) and 00850007135065 (Emerald Tor
10840162099996Kit containing 1x 00850007135003 (Emerald, oprifocon A, Blue) China Distribution
10840162099989Kit containing 1x 00850007135010 (Emerald Advance, oprifocon A, Green) China Distribution
10840162099972Kit containing 1x 00850007135058 (Emerald Advance Toric, oprifocon A, Blue) China Distribution
10840162099965Kit containing 1x 00850007135065 (Emerald Advance Toric, oprifocon A, Green) China Distribution
10840162000350Kit containing 00850007135058 (Emerald Essential Toric, oprifocon A, Blue) and 00850007135065 (E
10840162000343Kit containing 00850007135058 (Emerald Advance Toric, oprifocon A, Blue) and 00850007135065 (Eme
10840162000336Kit containing 00850007135003 (Emerald Essential, oprifocon A, Blue) and 00850007135010 (Emerald
10840162000329Kit containing 00850007135003 (Emerald Advance, oprifocon A, Blue) and 00850007135010 (Emerald A
10840162000312Kit containing 2x 00850007135065 (Emerald Essential Toric, oprifocon A, Green) China Distributio
10840162000305Kit containing 2x 00850007135065 (Emerald Advance Toric, oprifocon A, Green) China Distribution
10840162000299Kit containing 2x 00850007135058 (Emerald Essential Toric, oprifocon A, Blue) China Distribution
10840162000282Kit containing 2x 00850007135058 (Emerald Advance Toric, oprifocon A, Blue) China Distribution
10840162000275Kit containing 2x 00850007135010 (Emerald Essential, oprifocon A, Green) China Distribution
10840162000268Kit containing 2x 00850007135010 (Emerald Advance, oprifocon A, Green) China Distribution
10840162000251Kit containing 2x 00850007135003 (Emerald Essential, oprifocon A, Blue) China Distribution
10840162000244Kit containing 2x 00850007135003 (Emerald Advance, oprifocon A, Blue) China Distribution
10840162000213Kit containing 1x 00850007135065 (Emerald Essential Toric, oprifocon A, Green) China Distributio
10840162000206Kit containing 1x 00850007135058 (Emerald Essential Toric, oprifocon A, Blue) China Distribution
10840162000190Kit containing 1x 00850007135010 (Emerald Essential, oprifocon A, Green) China Distribution
10840162000183Kit containing 1x 00850007135003 (Emerald Essential, oprifocon A, Blue) China Distribution
00850007135546Kit containing 1x 00850007135065 (Emerald Toric, oprifocon A, Green) China Distribution; Alterna
00850007135539Kit containing 1x 00850007135058 (Emerald Toric, oprifocon A, Blue) China Distribution; Alternat
00850007135522Kit containing 1x 00850007135010 (Emerald, oprifocon A, Green) China Distribution; Alternate Tri
00850007135515Kit containing 1x 00850007135003 (Emerald, oprifocon A, Blue) China Distribution; Alternate Tria
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