Grooved Sponge

GUDID 18713210001321

Labtician Ophthalmics, Inc

Scleral buckling device, bioabsorbable

• Primary Device ID: 18713210001321
• NIH Device Record Key: 2045b3d8-3364-4185-98ca-bfe343b6d2d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Grooved Sponge
• Version Model Number: S 1983-2.3
• 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	08713210000167 [Unit of Use]
GS1	18713210001321 [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 Sponge]

• 18713210001406: S 1983-7.5
• 18713210001390: S 1983-3
• 18713210001383: S 1983-4
• 18713210001376: S 1983-3.5
• 18713210001369: S 1983-3.2
• 18713210001352: S 1983-3
• 18713210001321: S 1983-2.3
• 10871321001406: S 1983-7.5
• 10871321001390: S 1983-3
• 10871321001383: S 1983-4
• 10871321001376: S 1983-3.5
• 10871321001352: S 1983-3
• 10871321001321: S 1983-2.3
• 10871321001369: S 1983-3.2