3.0mm Round Sponge

GUDID 18713210001253

3.0mm Round Sponge

Labtician Ophthalmics, Inc

Scleral buckling device, bioabsorbable

• Primary Device ID: 18713210001253
• NIH Device Record Key: d6488857-1ec0-40b3-9a05-56aaa7fb7fa4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.0mm Round Sponge
• Version Model Number: S 1982-3-M
• 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	08713210000099 [Unit of Use]
GS1	18713210001253 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K875014

FDA Product Code

• HQJ: Implant, Absorbable, (Scleral Buckling Methods)

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 [3.0mm Round Sponge]

• 18713210001253: 3.0mm Round Sponge
• 10871321001253: 3.0mm Round Sponge