keraSys TK-41015

GUDID 00850853006342

Bio-engineered patch graft

Innovative Ophthalmic Products, Inc

Eyelid graft Eyelid xenograft Eyelid xenograft Eyelid xenograft Eyelid xenograft Eyelid xenograft Eyelid xenograft Eyelid xenograft Eyelid xenograft Eyelid xenograft

• Primary Device ID: 00850853006342
• NIH Device Record Key: 20e36532-7e30-4e5e-a762-3cce8a8bc116
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: keraSys
• Version Model Number: TK-41015
• Catalog Number: TK-41015
• Company DUNS: 793362583
• Company Name: Innovative Ophthalmic Products, Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: 800-535-3545
• Email: orders@iopinc.com
• Phone: 800-535-3545
• Email: orders@iopinc.com
• Phone: 800-535-3545
• Email: orders@iopinc.com
• Phone: 800-535-3545
• Email: orders@iopinc.com
• Phone: 800-535-3545
• Email: orders@iopinc.com
• Phone: 800-535-3545
• Email: orders@iopinc.com
• Phone: 800-535-3545
• Email: orders@iopinc.com
• Phone: 800-535-3545
• Email: orders@iopinc.com
• Phone: 800-535-3545
• Email: orders@iopinc.com
• Phone: 800-535-3545
• Email: orders@iopinc.com

Device Dimensions

• Length: 1.5 Centimeter
• Length: 1.5 Centimeter
• Width: 1 Centimeter
• Length: 1.5 Centimeter
• Width: 1 Centimeter
• Length: 1.5 Centimeter
• Width: 1 Centimeter
• Length: 1.5 Centimeter
• Width: 1 Centimeter
• Length: 1.5 Centimeter
• Width: 1 Centimeter
• Length: 1.5 Centimeter
• Width: 1 Centimeter
• Length: 1.5 Centimeter
• Width: 1 Centimeter
• Length: 1.5 Centimeter
• Width: 1 Centimeter
• Length: 1.5 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850853006342 [Primary]

FDA Product Code

• NXM: Prosthesis, Eyelid Spacer/Graft, Biologic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-01-06

Devices Manufactured by Innovative Ophthalmic Products, Inc

• 00850853006328 - tarSys: 2018-03-29 Bio-engineered eyelid spacer graft 8 layer 1 x 4 cm
• 00850853006335 - tarSys: 2018-03-29 Bio-engineered eyelid spacer 12 layer 1 x 4 cm
• 00850853006342 - keraSys: 2018-03-29Bio-engineered patch graft
• 00850853006342 - keraSys: 2018-03-29 Bio-engineered patch graft