CardioWrap®

Basic Information

• Brand Name: CardioWrap®
• Primary DI: 08964050362049
• Version / Model: 130 x 200 x 0.02mm
• Catalog Number: 36204-01
• Company Name: MAST BIOSURGERY USA INC.
• Labeler DUNS: 188582360
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-23
• Public Version: 6
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 4f7a89e3-f3c3-4707-bf23-ee8f957c3d33
• Distribution End Date: 2020-11-10

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OMH	Pericardial Patch To Facilitate Revision Surgeries	Cardiovascular	870.3470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44688	Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable	An implantable material (e.g., flat sheet) made from a bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	18964050362046	GS1	5 unit box	5	Not in Commercial Distribution	2020-11-10
Primary	08964050362049	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K031785	000

Device Sizes

Type	Value	Unit	Text
Width	130	Millimeter
Length	200	Millimeter
Device Size Text, specify			Thickness: 0.02 Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit