FDA.reportPublic FDA data

SurgiWrap®

Primary DI
18964050275063
Brand
SurgiWrap®
Company
MAST BIOSURGERY USA INC.
Model
180 x 280 x 0.05mm
Catalog number
27506-01
Device description
Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L-lactide). To be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. Minimizes tissue attachments to the device in case of direct contact with the viscera. Indicated for open and laparoscopic procedures.
Published
2015-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTLMesh, Surgical, Polymeric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050332000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050332000SURGI-WRAP MAST BIORESORBABLE SHEETMast Biosurgery USA, Inc.2005-05-27FTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18964050275063PackageGS15In Commercial Distribution
08964050275066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1896405027506318964050275063
08964050275066089640502750668964050275066

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, synthetic polymer, bioabsorbableA flat or three-dimensional (3-D), woven/knitted or porous implantable device made of a bioabsorbable synthetic polymer [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for multiple defective tissue repair applications at different anatomical zones (e.g., breast, cardiac, abdominal) that includes an extra-abdominal application(s) [e.g., cardiac, plastic surgery, breast reconstruction]. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length280Millimeter
Width180Millimeter

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00810057380266CardioWrap130 x 200 x 0.05mm36504-012020-11-11
00810057380389OrthoWrap50mm x 70mm x 0.02mm47201-012020-11-10

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Primary DI, Brand, Company table
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