CorMatrix(R) Cor(TM) PATCH Epicardial Patch, Five Pack, 5cm x 5cm

GUDID 00850003965000

CorMatrix Cor PATCH is intended for epicardial tissue support and repair.

CORMATRIX CARDIOVASCULAR, INC.

Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived

• Primary Device ID: 00850003965000
• NIH Device Record Key: cf104265-5b16-4770-8d06-c282844be3da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CorMatrix(R) Cor(TM) PATCH Epicardial Patch, Five Pack, 5cm x 5cm
• Version Model Number: CMCP5P-055
• Company DUNS: 601217164
• Company Name: CORMATRIX CARDIOVASCULAR, INC.
• Device Count: 1
• 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: 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

Device Dimensions

• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003965000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181038

FDA Product Code

• PSQ: Intracardiac Patch Or Pledget, Biologically Derived

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-18
• Device Publish Date: 2018-12-18

Devices Manufactured by CORMATRIX CARDIOVASCULAR, INC.

• 00850003965000 - CorMatrix(R) Cor(TM) PATCH Epicardial Patch, Five Pack, 5cm x 5cm: 2019-01-18CorMatrix Cor PATCH is intended for epicardial tissue support and repair.
• 00850003965000 - CorMatrix(R) Cor(TM) PATCH Epicardial Patch, Five Pack, 5cm x 5cm: 2019-01-18 CorMatrix Cor PATCH is intended for epicardial tissue support and repair.
• 00850003965017 - CorMatrix(R) Cor(TM) PATCH Epicardial Patch, Five Pack, 7cm x 10cm: 2019-01-18 CorMatrix Cor PATCH is intended for epicardial tissue support and repair.