Artisan 204US1W11N

GUDID 08717819060133

Artisan Myopia 6/8.5mm -5.5D

Ophtec B.V.

Anterior-chamber intraocular lens, phakic

• Primary Device ID: 08717819060133
• NIH Device Record Key: d0fbb3ba-9131-43ba-ad5b-b20104ec7175
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Artisan
• Version Model Number: 204US1W
• Catalog Number: 204US1W11N
• Company DUNS: 405048120
• Company Name: Ophtec B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com
• Phone: +31505251944
• Email: info@ophtec.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717819060133 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030028

FDA Product Code

• MTA: Lens, Intraocular, Phakic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-07-08
• Device Publish Date: 2015-08-25

On-Brand Devices [Artisan]

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• 08717819060638: Artisan Myopia 5/8.5mm -20.0D
• 08717819060621: Artisan Myopia 5/8.5mm -19.5D
• 08717819060614: Artisan Myopia 5/8.5mm -19.0D
• 08717819060607: Artisan Myopia 5/8.5mm -18.5D
• 08717819060591: Artisan Myopia 5/8.5mm -18.0D
• 08717819060584: Artisan Myopia 5/8.5mm -17.5D
• 08717819060577: Artisan Myopia 5/8.5mm -17.0D
• 08717819060560: Artisan Myopia 5/8.5mm -16.5D
• 08717819060553: Artisan Myopia 5/8.5mm -16.0D
• 08717819060546: Artisan Myopia 5/8.5mm -15.5D
• 08717819060539: Artisan Myopia 5/8.5mm -15.0D
• 08717819060522: Artisan Myopia 5/8.5mm -14.5D
• 08717819060515: Artisan Myopia 5/8.5mm -14.0D
• 08717819060508: Artisan Myopia 5/8.5mm -13.5D
• 08717819060492: Artisan Myopia 5/8.5mm -13.0D
• 08717819060485: Artisan Myopia 5/8.5mm -12.5D
• 08717819060478: Artisan Myopia 5/8.5mm -12.0D
• 08717819060461: Artisan Myopia 5/8.5mm -11.5D
• 08717819060454: Artisan Myopia 5/8.5mm -11.0D
• 08717819060447: Artisan Myopia 5/8.5mm -10.5D
• 08717819060430: Artisan Myopia 5/8.5mm -10.0D
• 08717819060423: Artisan Myopia 5/8.5mm -9.5D
• 08717819060416: Artisan Myopia 5/8.5mm -9.0D
• 08717819060409: Artisan Myopia 5/8.5mm -8.5D
• 08717819060393: Artisan Myopia 5/8.5mm -8.0D
• 08717819060386: Artisan Myopia 5/8.5mm -7.5D
• 08717819060379: Artisan Myopia 5/8.5mm -7.0D
• 08717819060362: Artisan Myopia 5/8.5mm -6.5D
• 08717819060355: Artisan Myopia 5/8.5mm -6.0D
• 08717819060348: Artisan Myopia 5/8.5mm -5.5D
• 08717819060331: Artisan Myopia 5/8.5mm -5.0D
• 08717819060324: Artisan Myopia 6/8.5mm -15.0D
• 08717819060317: Artisan Myopia 6/8.5mm -14.5D
• 08717819060300: Artisan Myopia 6/8.5mm -14.0D
• 08717819060294: Artisan Myopia 6/8.5mm -13.5D
• 08717819060287: Artisan Myopia 6/8.5mm -13.0D
• 08717819060270: Artisan Myopia 6/8.5mm -12.5D
• 08717819060263: Artisan Myopia 6/8.5mm -12.0D
• 08717819060256: Artisan Myopia 6/8.5mm -11.5D
• 08717819060249: Artisan Myopia 6/8.5mm -11.0D
• 08717819060232: Artisan Myopia 6/8.5mm -10.5D
• 08717819060225: Artisan Myopia 6/8.5mm -10.0D
• 08717819060218: Artisan Myopia 6/8.5mm -9.5D
• 08717819060201: Artisan Myopia 6/8.5mm -9.0D
• 08717819060195: Artisan Myopia 6/8.5mm -8.5D
• 08717819060188: Artisan Myopia 6/8.5mm -8.0D
• 08717819060171: Artisan Myopia 6/8.5mm -7.5D
• 08717819060164: Artisan Myopia 6/8.5mm -7.0D
• 08717819060157: Artisan Myopia 6/8.5mm -6.5D