OrthoWrap 47501-01

GUDID 00810057380334

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.

MAST BIOSURGERY USA INC.

Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Primary Device ID00810057380334
NIH Device Record Keybc3826a7-b133-4ef8-8d30-ae6f6c3b00a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthoWrap
Version Model Number50mm x 70mm x 0.05mm
Catalog Number47501-01
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810057380334 [Package]
Contains: 00810057380402
Package: 5 unit box [5 Units]
In Commercial Distribution
GS100810057380402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTLMesh, Surgical, Polymeric

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-06-10
Device Publish Date2020-11-10

On-Brand Devices [OrthoWrap]

00810057380334Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L
00810057380389Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L

Trademark Results [OrthoWrap]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ORTHOWRAP
ORTHOWRAP
77222458 3442044 Live/Registered
MAST Biosurgry AG
2007-07-05

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