Artisan/Artiflex OD125A

GUDID 08717819049176

Enclavation Needles

Ophtec B.V.

Ocular hook/spatula/manipulator, single-use

• Primary Device ID: 08717819049176
• NIH Device Record Key: d771ab9c-6080-4042-a86e-e611b66d6742
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Artisan/Artiflex
• Version Model Number: OD125A
• Catalog Number: OD125A
• 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: false
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
• Special Storage Condition, Specify: Between 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
• Special Storage Condition, Specify: Between 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
• Special Storage Condition, Specify: Between 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
• Special Storage Condition, Specify: Between 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
• Special Storage Condition, Specify: Between 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
• Special Storage Condition, Specify: Between 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
• Special Storage Condition, Specify: Between 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
• Special Storage Condition, Specify: Between 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
• Special Storage Condition, Specify: Between 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
• Special Storage Condition, Specify: Between 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
• Special Storage Condition, Specify: Between 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
• Special Storage Condition, Specify: Between 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
• Special Storage Condition, Specify: Between 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
• Special Storage Condition, Specify: Between 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
• Special Storage Condition, Specify: Between 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
• Special Storage Condition, Specify: Between 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
• Special Storage Condition, Specify: Between 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717819049176 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030471

FDA Product Code

• MRJ: Ring, Endocapsular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-24
• Device Publish Date: 2018-09-24

Devices Manufactured by Ophtec B.V.

• 08717819047318 - Verisyse: 2021-07-08 Verisyse Myopia 5.0 mm -5.0D
• 08717819047325 - Verisyse: 2021-07-08 Verisyse Myopia 5.0 mm -5.5D
• 08717819047332 - Verisyse: 2021-07-08 Verisyse Myopia 5.0 mm -6.0D
• 08717819047349 - Verisyse: 2021-07-08 Verisyse Myopia 5.0 mm -6.5D
• 08717819047356 - Verisyse: 2021-07-08 Verisyse Myopia 5.0 mm -7.0D
• 08717819047363 - Verisyse: 2021-07-08 Verisyse Myopia 5.0 mm -7.5D
• 08717819047370 - Verisyse: 2021-07-08 Verisyse Myopia 5.0 mm -8.0D
• 08717819047387 - Verisyse: 2021-07-08 Verisyse Myopia 5.0 mm -8.5D