BondEase

GUDID 00850081858102

Topical Skin Adhesive

Optmed Inc

Skin-approximation adhesive

• Primary Device ID: 00850081858102
• NIH Device Record Key: 9a034b3c-6592-4471-9a10-050285ce50d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BondEase
• Version Model Number: BE100
• Company DUNS: 026944109
• Company Name: Optmed 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	00850081858102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243990

FDA Product Code

• MPN: Tissue Adhesive For The Topical Approximation Of Skin

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: 2026-03-30
• Device Publish Date: 2026-03-20

Devices Manufactured by Optmed Inc

• 00850081858102 - BondEase: 2026-03-30Topical Skin Adhesive
• 00850081858102 - BondEase: 2026-03-30 Topical Skin Adhesive
• 00850081858003 - NaavaBond: 2026-01-23 Topical Skin Adhesive
• 00860013046415 - TearRepair: 2025-06-09