FDA.reportPublic FDA data

OrthoWrap

Primary DI
00810057380389
Brand
OrthoWrap
Company
MAST BIOSURGERY USA INC.
Model
50mm x 70mm x 0.02mm
Catalog number
47201-01
Device description
Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L-lactide). To be used for management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. Minimizes tissue attachment to the device in case of direct contact with the tissues. Also indicated for reinforcement of soft tissues repaired by suture or suture anchors, during tendon repair surgery. Reinforces soft tissue and provides a remodelable scaffold that is replaced by the patient’s own soft tissue. The device is indicated for open and laparoscopic/endoscopic procedures.
Published
2020-11-10
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
FTLMesh, Surgical, Polymeric

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072190000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072190000ORTHO-WRAP BIORESORBABLE SHEETMast Biosurgery2008-01-16FTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810057380327PackageGS15In Commercial Distribution
00810057380389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810057380327008100573803278100573803270810057380327
00810057380389008100573803898100573803890810057380389

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
00810057380266CardioWrap130 x 200 x 0.05mm36504-012020-11-11
08964050272010SurgiWrap®50 x 70 x 0.02mm27201-012015-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09421907331997OviTex® 1SAROA BIOSURGERY LIMITEDFTL2025-11-26
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09421908222089OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222119OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222126OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222140OviTex® InguinalAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222263OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
10884521857179ParieteneSOFRADIM PRODUCTIONFTL2025-11-08
08903837165978Surgical MeshHEALTHIUM MEDTECH LIMITEDFTL2023-08-31
09421906661552OviTex® LPRAROA BIOSURGERY LIMITEDFTL2023-06-15
09421906661569OviTex® LPRAROA BIOSURGERY LIMITEDFTL2023-06-15
10705031085978ULTRAPROJohnson & Johnson International Inc.FTL2022-11-08
10705031085985ULTRAPROJohnson & Johnson International Inc.FTL2022-11-08
10607567510996TigerPaw Pro Left Atrial Appendage Closure DeviceDATASCOPE CORP.FTL2020-11-18
09421905067539OviTex® LPRAROA BIOSURGERY LIMITEDFTL2020-03-13
10884521784086Parietene DSSOFRADIM PRODUCTIONFTL2020-01-26
10884521784093Parietene DSSOFRADIM PRODUCTIONFTL2020-01-26
10884521784109Parietene DSSOFRADIM PRODUCTIONFTL2020-01-26
10884521784123Parietene DSSOFRADIM PRODUCTIONFTL2020-01-26
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09421905067645Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01
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09421905067751Ovitex® PRSAROA BIOSURGERY LIMITEDFTL2019-11-01