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.

Multi-purpose surgical mesh, synthetic polymer, bioabsorbable
Primary Device ID18964050365047
NIH Device Record Key91d97f19-518b-4147-8e6b-3b764afa838a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardioWrap®
Version Model Number130 x 200 x 0.05mm
Catalog Number36504-01
Company DUNS188582360
Company NameMAST BIOSURGERY USA INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-627-8246
EmailCustomerService@mastbio.com
Phone866-627-8246
EmailCustomerService@mastbio.com
Phone866-627-8246
EmailCustomerService@mastbio.com
Phone866-627-8246
EmailCustomerService@mastbio.com
Phone866-627-8246
EmailCustomerService@mastbio.com
Phone866-627-8246
EmailCustomerService@mastbio.com
Phone866-627-8246
EmailCustomerService@mastbio.com
Phone866-627-8246
EmailCustomerService@mastbio.com
Phone866-627-8246
EmailCustomerService@mastbio.com
Phone866-627-8246
EmailCustomerService@mastbio.com
Phone866-627-8246
EmailCustomerService@mastbio.com
Phone866-627-8246
EmailCustomerService@mastbio.com
Phone866-627-8246
EmailCustomerService@mastbio.com
Phone866-627-8246
EmailCustomerService@mastbio.com

Device Dimensions

Device Size Text, specify0
Length200 Millimeter
Width130 Millimeter
Device Size Text, specify0
Length200 Millimeter
Width130 Millimeter
Device Size Text, specify0
Length200 Millimeter
Width130 Millimeter
Device Size Text, specify0
Length200 Millimeter
Width130 Millimeter
Device Size Text, specify0
Length200 Millimeter
Width130 Millimeter
Device Size Text, specify0
Length200 Millimeter
Width130 Millimeter
Device Size Text, specify0
Length200 Millimeter
Width130 Millimeter
Device Size Text, specify0
Length200 Millimeter
Width130 Millimeter
Device Size Text, specify0
Length200 Millimeter
Width130 Millimeter
Device Size Text, specify0
Length200 Millimeter
Width130 Millimeter
Device Size Text, specify0
Length200 Millimeter
Width130 Millimeter
Device Size Text, specify0
Length200 Millimeter
Width130 Millimeter
Device Size Text, specify0
Length200 Millimeter
Width130 Millimeter
Device Size Text, specify0
Length200 Millimeter
Width130 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS108964050365040 [Primary]
GS118964050365047 [Package]
Contains: 08964050365040
Package: 5 unit box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OMHPericardial Patch To Facilitate Revision Surgeries

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-10-21
Device Publish Date2015-10-23

On-Brand Devices [CardioWrap®]

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

Trademark Results [CardioWrap]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CARDIOWRAP
CARDIOWRAP
76462622 3286682 Live/Registered
MAST BIOSURGERY AG
2002-10-28

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