Oval Sponge

GUDID 18713210001208

Oval Sponge

Labtician Ophthalmics, Inc

Scleral buckling device, bioabsorbable

• Primary Device ID: 18713210001208
• NIH Device Record Key: e457fc26-d3f2-42d1-8dab-e06b7be5e843
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oval Sponge
• Version Model Number: S 1981-7.5
• Company DUNS: 248911026
• Company Name: Labtician Ophthalmics, Inc
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 905-829-0055
• Email: philcuscuna@labtician.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08713210000044 [Unit of Use]
GS1	18713210001208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K875014

FDA Product Code

• HQX: Implant, Orbital, Extra-Ocular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-12
• Device Publish Date: 2018-02-22

On-Brand Devices [Oval Sponge]

• 18713210001192: S 1981-7
• 18713210001185: S 1981-5
• 18713210001178: S 1981-4
• 18713210001208: Oval Sponge
• 10871321001208: Oval Sponge
• 10871321001192: S 1981-7
• 10871321001185: S 1981-5
• 10871321001178: S 1981-4