Silicone Sleeve

GUDID 18713210001932

Labtician Ophthalmics, Inc

Scleral buckling device, bioabsorbable

• Primary Device ID: 18713210001932
• NIH Device Record Key: da12cacc-da74-415e-b871-5a5ce4f14bb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Sleeve
• Version Model Number: S 3071
• 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
• Phone: 905-829-0055
• Email: philcuscuna@labtician.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08713210000792 [Unit of Use]
GS1	18713210001932 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-09

On-Brand Devices [Silicone Sleeve]

• 18713210001932: S 3071
• 18713210001895: S 3019
• 18713210001888: S 3018
• 10871321001932: S 3071
• 10871321001895: S 3019
• 10871321001888: S 3018