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

GUDID 85000713500133

Emerald, oprifocon A, Green

EUCLID SYSTEMS CORPORATION

Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens Orthokeratology contact lens
Primary Device ID85000713500133
NIH Device Record Key9a928d16-9a90-420b-bc77-91e66fcdbe6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameEuclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear
Version Model NumberEmerald
Company DUNS969263979
Company NameEUCLID SYSTEMS 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

Customer Support Contacts

Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com
Phone1-(800) 477-9396
EmailUDI@euclidsys.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850007135034 [Primary]
GS185000713500034 [Package]
Contains: 00850007135034
Package: Deep Well Pillow Pk [1 Units]
In Commercial Distribution
GS185000713500133 [Package]
Contains: 00850007135034
Package: Flat Pack Pillow Pk [1 Units]
In Commercial Distribution

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-03
Device Publish Date2019-07-19

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

85000713500232Kit containing 850007135072(Emerald Toric, opirfocon A, Blue) and 850007135089(Emerald Toric, op
85000713500225Kit containing 850007135058 (Emerald Toric, oprifocon A, Blue) and 850007135065 (Emerald Toric,
85000713500218Kit containing 00850007135027 (Emerald, oprifocon A, Blue) and 00850007135034 (Emerald, oprifoco
85000713500188Emerald Toric, oprifocon A, Green
85000713500171Emerald Toric, opirfocon A, Blue
85000713500164Emerald Toric, oprifocon A, Green
85000713500157Emerald Toric, oprifocon A, Blue
85000713500133Emerald, oprifocon A, Green
85000713500126Emerald, oprifocon A, Blue
85000713500119Emerald, oprifocon A, Green
85000713500102Emerald, oprifocon A, Blue
85000713599984Kit containing 850007135027 (Emerald, oprifocon A, Blue) and 850007135034 (Emerald, oprifocon A,
85000713599991Kit containing 850007135003 (Emerald, oprifocon A, Blue) and 850007135010 (Emerald, oprifocon A
85000713599960Kit containing 850007135072 (Emerald Toric, opirfocon A, Blue) and 850007135089 (Emerald Toric,
85000713599977Kit containing 850007135058 (Emerald Toric, oprifocon A, blue) and 850007135065 (Emerald Toric,

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