EYEJET® CTR Type 20C Right

GUDID 04048509620004

SINGLE-USE PRE-LOADED CAPSULAR TENSION RING

Morcher GmbH

Capsular tension ring Capsular tension ring Capsular tension ring Capsular tension ring Capsular tension ring Capsular tension ring Capsular tension ring Capsular tension ring Capsular tension ring Capsular tension ring Capsular tension ring Capsular tension ring Capsular tension ring Capsular tension ring Capsular tension ring Capsular tension ring Capsular tension ring

• Primary Device ID: 04048509620004
• NIH Device Record Key: 83b266af-99c9-4be8-9590-1726608e4784
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EYEJET® CTR Type 20C Right
• Version Model Number: 20C RIGHT V.1
• Company DUNS: 327283586
• Company Name: Morcher GmbH
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store horizontally at room temperature!, Keep dry, Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store horizontally at room temperature!, Keep dry, Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store horizontally at room temperature!, Keep dry, Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store horizontally at room temperature!, Keep dry, Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store horizontally at room temperature!, Keep dry, Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store horizontally at room temperature!, Keep dry, Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store horizontally at room temperature!, Keep dry, Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store horizontally at room temperature!, Keep dry, Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store horizontally at room temperature!, Keep dry, Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store horizontally at room temperature!, Keep dry, Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store horizontally at room temperature!, Keep dry, Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store horizontally at room temperature!, Keep dry, Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store horizontally at room temperature!, Keep dry, Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store horizontally at room temperature!, Keep dry, Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store horizontally at room temperature!, Keep dry, Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store horizontally at room temperature!, Keep dry, Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store horizontally at room temperature!, Keep dry, Keep away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048509620004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010059

FDA Product Code

• MRJ: Ring, Endocapsular

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-22
• Device Publish Date: 2023-09-14