PROKERA® PK-16

GUDID 00855928005121

PROKERA® Biologic Corneal Bandage

TISSUETECH, INC

Ophthalmic conformer

• Primary Device ID: 00855928005121
• NIH Device Record Key: 28009c58-7687-4922-aef8-156c260dd4ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROKERA®
• Version Model Number: PROKERA®
• Catalog Number: PK-16
• Company DUNS: 167232888
• Company Name: TISSUETECH, 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: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855928005121 [Primary]

FDA Product Code

• NQB: Conformer, Ophthalmic, Biological Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-05

On-Brand Devices [PROKERA®]

• 00855928005442: PROKERA® CLEAR Biologic Corneal Bandage
• 00855928005145: PROKERA® PLUS Biologic Corneal Bandage
• 00855928005138: PROKERA® SLIM Biologic Corneal Bandage
• 00855928005121: PROKERA® Biologic Corneal Bandage