Ophthalmic Conformer D120810

GUDID G290V2628

Midwest Eye Laboratories Woodbury, LLC

Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer
Primary Device IDG290V2628
NIH Device Record Keya49b45f9-4bc3-46f9-ad45-4c056495fbe9
Commercial Distribution StatusIn Commercial Distribution
Brand NameOphthalmic Conformer
Version Model NumberV2628
Catalog NumberD120810
Company DUNS809338473
Company NameMidwest Eye Laboratories Woodbury, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6517394111
Emailinfo@midwesteyelabs.com
Phone6517394111
Emailinfo@midwesteyelabs.com
Phone6517394111
Emailinfo@midwesteyelabs.com
Phone6517394111
Emailinfo@midwesteyelabs.com
Phone6517394111
Emailinfo@midwesteyelabs.com
Phone6517394111
Emailinfo@midwesteyelabs.com
Phone6517394111
Emailinfo@midwesteyelabs.com
Phone6517394111
Emailinfo@midwesteyelabs.com
Phone6517394111
Emailinfo@midwesteyelabs.com
Phone6517394111
Emailinfo@midwesteyelabs.com
Phone6517394111
Emailinfo@midwesteyelabs.com
Phone6517394111
Emailinfo@midwesteyelabs.com
Phone6517394111
Emailinfo@midwesteyelabs.com
Phone6517394111
Emailinfo@midwesteyelabs.com
Phone6517394111
Emailinfo@midwesteyelabs.com
Phone6517394111
Emailinfo@midwesteyelabs.com
Phone6517394111
Emailinfo@midwesteyelabs.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 110 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG290V2628 [Primary]

FDA Product Code

HQNConformer, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-28
Device Publish Date2024-02-20

Devices Manufactured by Midwest Eye Laboratories Woodbury, LLC

G290V2627 - Shell, Scleral2024-02-28
G290V2628 - Ophthalmic Conformer2024-02-28
G290V2628 - Ophthalmic Conformer2024-02-28
G290V2623 - Eye, Artificial, Non-Custom2024-02-27

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