Grooved Part Thickness Sponge

GUDID 18713210001338

Labtician Ophthalmics, Inc

Scleral buckling device, bioabsorbable

• Primary Device ID: 18713210001338
• NIH Device Record Key: a5fb6a20-e3ad-4561-9f2b-aa38f422a884
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Grooved Part Thickness Sponge
• Version Model Number: S 1983-2.5
• 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
• Phone: 905-829-0055
• Email: philcuscuna@labtician.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08713210000174 [Unit of Use]
GS1	18713210001338 [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: 2015-10-05

On-Brand Devices [Grooved Part Thickness Sponge]

• 18713210001345: S 1983-2.8
• 18713210001338: S 1983-2.5
• 10871321001345: S 1983-2.8
• 10871321001338: S 1983-2.5