Cenefom

GUDID 04711552929683

LASIK Ring 12mm

CENEFOM CORP.

Ophthalmic sponge

• Primary Device ID: 04711552929683
• NIH Device Record Key: 4b3bede1-9ffe-466f-86e5-e97bec5078c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cenefom
• Version Model Number: OP-LR02
• Company DUNS: 658868262
• Company Name: CENEFOM CORP.
• Device Count: 20
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04711552929676 [Unit of Use]
GS1	04711552929683 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082460

FDA Product Code

• HOZ: Sponge, Ophthalmic

Sterilization

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

[04711552929683]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-31

On-Brand Devices [Cenefom]

• 04711552929782: Wipe
• 04711552929751: LASIK eye drain 12mm
• 04711552929683: LASIK Ring 12mm
• 04711552920352: Corneal light shield
• 04711552920321: Epistaxis Type Nasal Packing