Inlay Inserter Chuck Handle 607-0002

GUDID 10850394006051

The Inlay Inserter Chuck Handle is used in conjunction with the Inlay Inserter to extend the length of the device for ease of use while delivering the Raindrop® Near Vision Inlay. The Inserter Handle has three components: the handle, the sleeve, and the chuck.

REVISION OPTICS, INC.

Ophthalmic surgical instrument handle, manual, reusable

• Primary Device ID: 10850394006051
• NIH Device Record Key: 4bcb5c74-d5ed-4708-961d-df887e9282ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inlay Inserter Chuck Handle
• Version Model Number: 607-0002
• Catalog Number: 607-0002
• Company DUNS: 015504442
• Company Name: REVISION OPTICS, INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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: 949-707-2740
• Email: customerservice@revisionoptics.com
• Phone: 949-707-2740
• Email: customerservice@revisionoptics.com
• Phone: 949-707-2740
• Email: customerservice@revisionoptics.com
• Phone: 949-707-2740
• Email: customerservice@revisionoptics.com
• Phone: 949-707-2740
• Email: customerservice@revisionoptics.com
• Phone: 949-707-2740
• Email: customerservice@revisionoptics.com
• Phone: 949-707-2740
• Email: customerservice@revisionoptics.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *In between use, store the packaged instrument in a dry and clean environment.
• Special Storage Condition, Specify: Between 0 and 0 *In between use, store the packaged instrument in a dry and clean environment.
• Special Storage Condition, Specify: Between 0 and 0 *In between use, store the packaged instrument in a dry and clean environment.
• Special Storage Condition, Specify: Between 0 and 0 *In between use, store the packaged instrument in a dry and clean environment.
• Special Storage Condition, Specify: Between 0 and 0 *In between use, store the packaged instrument in a dry and clean environment.
• Special Storage Condition, Specify: Between 0 and 0 *In between use, store the packaged instrument in a dry and clean environment.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10850394006051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150034

FDA Product Code

• LQE: Implant, Corneal, Refractive

Sterilization

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

[10850394006051]

Moist Heat or Steam Sterilization

[10850394006051]

Moist Heat or Steam Sterilization

[10850394006051]

Moist Heat or Steam Sterilization

[10850394006051]

Moist Heat or Steam Sterilization

[10850394006051]

Moist Heat or Steam Sterilization

[10850394006051]

Moist Heat or Steam Sterilization

[10850394006051]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2026-01-12
• Device Publish Date: 2016-08-19