OASIS® Iris Expander

GUDID 10845819000455

OASIS® Iris Expander, 6.25mm

OASIS MEDICAL, INC.

Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use

• Primary Device ID: 10845819000455
• NIH Device Record Key: c2a0d9cb-f86b-4997-85ea-e2fef2f03fd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OASIS® Iris Expander
• Version Model Number: 9625, 9625-S
• Company DUNS: 194121018
• Company Name: OASIS MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 9093055400
• Email: customerservice@oasismedical.com
• Phone: 9093055400
• Email: customerservice@oasismedical.com
• Phone: 9093055400
• Email: customerservice@oasismedical.com
• Phone: 9093055400
• Email: customerservice@oasismedical.com
• Phone: 9093055400
• Email: customerservice@oasismedical.com
• Phone: 9093055400
• Email: customerservice@oasismedical.com
• Phone: 9093055400
• Email: customerservice@oasismedical.com
• Phone: 9093055400
• Email: customerservice@oasismedical.com
• Phone: 9093055400
• Email: customerservice@oasismedical.com
• Phone: 9093055400
• Email: customerservice@oasismedical.com
• Phone: 9093055400
• Email: customerservice@oasismedical.com
• Phone: 9093055400
• Email: customerservice@oasismedical.com
• Phone: 9093055400
• Email: customerservice@oasismedical.com
• Phone: 9093055400
• Email: customerservice@oasismedical.com
• Phone: 9093055400
• Email: customerservice@oasismedical.com
• Phone: 9093055400
• Email: customerservice@oasismedical.com
• Phone: 9093055400
• Email: customerservice@oasismedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845819000458 [Primary]
GS1	10845819000455 [Package]; Contains: 00845819000458; Package: Carton [5 Units]; In Commercial Distribution
GS1	20845819000452 [Package]; Contains: 00845819000458; Package: Carton [1 Units]; In Commercial Distribution

FDA Product Code

• HOC: Clip, Iris Retractor

Sterilization

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

[10845819000455]

Ethylene Oxide

[10845819000455]

Ethylene Oxide

[10845819000455]

Ethylene Oxide

[10845819000455]

Ethylene Oxide

[10845819000455]

Ethylene Oxide

[10845819000455]

Ethylene Oxide

[10845819000455]

Ethylene Oxide

[10845819000455]

Ethylene Oxide

[10845819000455]

Ethylene Oxide

[10845819000455]

Ethylene Oxide

[10845819000455]

Ethylene Oxide

[10845819000455]

Ethylene Oxide

[10845819000455]

Ethylene Oxide

[10845819000455]

Ethylene Oxide

[10845819000455]

Ethylene Oxide

[10845819000455]

Ethylene Oxide

[10845819000455]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-10
• Device Publish Date: 2023-06-30

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