CardioWrap 36504-01

GUDID 00810057380266

Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L-lactide). Indicated for use 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: 00810057380266
• NIH Device Record Key: 7e815bb3-a251-4789-8fc3-c472aa947270
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810057380266 [Primary]

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: 2
• Public Version Date: 2022-06-10
• Device Publish Date: 2020-11-11

On-Brand Devices [CardioWrap]

• 00810057380266: Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L
• 00810057380259: Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L