ReSure Sealant

GUDID 00867968000004

OCULAR THERAPEUTIX, INC.

Wound hydrogel dressing, sterile

• Primary Device ID: 00867968000004
• NIH Device Record Key: ca10e586-459d-44d5-aae0-12f1049b26ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReSure Sealant
• Version Model Number: 5-Up
• Company DUNS: 063391985
• Company Name: OCULAR THERAPEUTIX, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867968000004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P130004

FDA Product Code

• PFZ: Ophthalmic Sealant

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: 2018-07-06
• Device Publish Date: 2014-09-23

On-Brand Devices [ReSure Sealant]

• 00867968000011: 10-Up
• 00867968000004: 5-Up