CardioWrap® 36504-01

GUDID 18964050365047

Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L-lactide). To be used as a pericardium replacement device in patients that may require re-operation within six months.

MAST BIOSURGERY USA INC.

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• Primary Device ID: 18964050365047
• NIH Device Record Key: 91d97f19-518b-4147-8e6b-3b764afa838a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioWrap®
• Version Model Number: 130 x 200 x 0.05mm
• Catalog Number: 36504-01
• Company DUNS: 188582360
• Company Name: MAST BIOSURGERY USA 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: 866-627-8246
• Email: CustomerService@mastbio.com
• Phone: 866-627-8246
• Email: CustomerService@mastbio.com
• Phone: 866-627-8246
• Email: CustomerService@mastbio.com
• Phone: 866-627-8246
• Email: CustomerService@mastbio.com
• Phone: 866-627-8246
• Email: CustomerService@mastbio.com
• Phone: 866-627-8246
• Email: CustomerService@mastbio.com
• Phone: 866-627-8246
• Email: CustomerService@mastbio.com
• Phone: 866-627-8246
• Email: CustomerService@mastbio.com
• Phone: 866-627-8246
• Email: CustomerService@mastbio.com
• Phone: 866-627-8246
• Email: CustomerService@mastbio.com
• Phone: 866-627-8246
• Email: CustomerService@mastbio.com
• Phone: 866-627-8246
• Email: CustomerService@mastbio.com
• Phone: 866-627-8246
• Email: CustomerService@mastbio.com
• Phone: 866-627-8246
• Email: CustomerService@mastbio.com

Device Dimensions

• Device Size Text, specify: 0
• Length: 200 Millimeter
• Width: 130 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Width: 130 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Width: 130 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Width: 130 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Width: 130 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Width: 130 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Width: 130 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Width: 130 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Width: 130 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Width: 130 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Width: 130 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Width: 130 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Width: 130 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Width: 130 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	08964050365040 [Primary]
GS1	18964050365047 [Package]; Contains: 08964050365040; Package: 5 unit box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031785

FDA Product Code

• OMH: Pericardial Patch To Facilitate Revision Surgeries

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-10-21
• Device Publish Date: 2015-10-23

On-Brand Devices [CardioWrap®]

• 18964050365047: Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L
• 18964050365023: Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L
• 18964050362046: Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L
• 18964050362022: Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L