FDA.reportPublic FDA data

CardioWrap

Primary DI
00810057380266
Brand
CardioWrap
Company
MAST BIOSURGERY USA INC.
Model
130 x 200 x 0.05mm
Catalog number
36504-01
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.
Published
2020-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OMHPericardial Patch To Facilitate Revision Surgeries

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMHPericardial Patch To Facilitate Revision SurgeriesCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031785000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031785000MACROPORE CARDIO-WRAP (TS)Macropore Biosurgery, Inc.2003-09-04OMH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810057380266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810057380266008100573802668100573802660810057380266

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbableAn 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-627-8246CustomerService@mastbio.com

Regulatory Flags#

DUNS number
188582360
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810057380006SurgiWrap FROST100 x 130 x 0.02mm57302-012025-08-21
00810057380013SurgiWrap FROST130 x 200 x 0.02mm57304-012025-08-21
00810057380020SurgiWrap FROST50 x 65 x 0.02mm57301-012025-08-21
08964050272041SurgiWrap®130 x 200 x 0.02mm27204-012015-10-23
08964050272065SurgiWrap®180 x 280 x 0.02mm27206-012015-10-23
08964050275066SurgiWrap®180 x 280 x 0.05mm27506-012015-10-23
08964050362025CardioWrap®100 x 130 x 0.02mm36202-012015-10-23
08964050362049CardioWrap®130 x 200 x 0.02mm36204-012015-10-23
08964050365026CardioWrap®100 x 130 x 0.05mm36502-012015-10-23
08964050365040CardioWrap®130 x 200 x 0.05mm36504-012015-10-23
08964050472014OrthoWrap®50 x 70 x 0.02mm47201-012015-10-23
08964050475015OrthoWrap®50 x 70 x 0.05mm47501-012015-10-23
00810057380150SurgiWrap130 x 200 x 0.02mm27204-012020-11-10
00810057380174SurgiWrap100 x 130 x 0.05mm27502-012020-11-11
00810057380402OrthoWrap50mm x 70mm x 0.05mm47501-012020-11-10
00810057380136SurgiWrap100 x 130 x 0.02mm27202-012020-11-10
00810057380198SurgiWrap130 x 200 x 0.05mm27504-012020-11-10
00810057380259CardioWrap100 x 130 x 0.05mm36502-012020-11-10
00810057380389OrthoWrap50mm x 70mm x 0.02mm47201-012020-11-10
08964050272010SurgiWrap®50 x 70 x 0.02mm27201-012015-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191072184023ACSAMERICAN CONTRACT SYSTEMS, INC.OMH2023-07-14
00810057380259CardioWrapMAST BIOSURGERY USA INC.OMH2020-11-10
08964050362025CardioWrap®MAST BIOSURGERY USA INC.OMH2015-10-23
08964050362049CardioWrap®MAST BIOSURGERY USA INC.OMH2015-10-23
08964050365026CardioWrap®MAST BIOSURGERY USA INC.OMH2015-10-23
08964050365040CardioWrap®MAST BIOSURGERY USA INC.OMH2015-10-23
18964050362022CardioWrap®MAST BIOSURGERY USA INC.OMH2015-10-23
18964050362046CardioWrap®MAST BIOSURGERY USA INC.OMH2015-10-23
18964050365023CardioWrap®MAST BIOSURGERY USA INC.OMH2015-10-23
18964050365047CardioWrap®MAST BIOSURGERY USA INC.OMH2015-10-23