FDA.reportPublic FDA data

OrthoWrap®

Primary DI
18964050472011
Brand
OrthoWrap®
Company
MAST BIOSURGERY USA INC.
Model
50 x 70 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
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
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
18964050472011PackageGS15In Commercial Distribution
08964050472014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1896405047201118964050472011
08964050472014089640504720148964050472014

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
Length70Millimeter
Width50Millimeter

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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