OviTex Reinforced Bioscaffold With Resorbable Polymer (OviTex) F10254-1020G

GUDID 09421904065246

OviTex™ Core Reinforced Tissue Matrix with Resorbable Polymer (OviTex) is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and polyglycolic acid (PGA). OviTex will incorporate into the recipient tissue with associated cellular and microvascular ingrowth. OviTex is provided in various shapes and sizes to suit surgeon preference and the complexity of the soft tissue repair. The device may be trimmed to a desired shape to further accommodate an individual patient’s requirements.

AROA BIOSURGERY LIMITED

Multi-purpose surgical mesh, collagen, bioabsorbable
Primary Device ID09421904065246
NIH Device Record Key4502f8a2-0d25-4f02-a23c-e269148db055
Commercial Distribution StatusIn Commercial Distribution
Brand NameOviTex Reinforced Bioscaffold With Resorbable Polymer (OviTex)
Version Model NumberF10254-1020G
Catalog NumberF10254-1020G
Company DUNS594540572
Company NameAROA BIOSURGERY LIMITED
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

Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com

Device Dimensions

Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter
Width20 Centimeter
Length10 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS109421904065246 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTMMesh, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-08-10
Device Publish Date2016-09-24

On-Brand Devices [OviTex Reinforced Bioscaffold With Resorbable Polymer (OviTex)]

09421904065413OviTex™ 2S Reinforced Tissue Matrix with Resorbable Polymer (OviTex 2S) is a sterile bioscaffo
09421904065406OviTex™ 2S Reinforced Tissue Matrix with Resorbable Polymer (OviTex 2S) is a sterile bioscaffo
09421904065390OviTex™ 2S Reinforced Tissue Matrix with Resorbable Polymer (OviTex 2S) is a sterile bioscaffo
09421904065383OviTex™ 2S Reinforced Tissue Matrix with Resorbable Polymer (OviTex 2S) is a sterile bioscaffo
09421904065376OviTex™ 2S Reinforced Tissue Matrix with Resorbable Polymer (OviTex 2S) is a sterile bioscaffo
09421904065369OviTex™ 2S Reinforced Tissue Matrix with Resorbable Polymer (OviTex 2S) is a sterile bioscaffo
09421904065352OviTex™ 2S Reinforced Tissue Matrix with Resorbable Polymer (OviTex 2S) is a sterile bioscaffo
09421904065345OviTex™ 1S Reinforced Tissue Matrix with Resorbable Polymer (OviTex 1S) is a sterile bioscaffo
09421904065338OviTex™ 1S Reinforced Tissue Matrix with Resorbable Polymer (OviTex 1S) is a sterile bioscaffo
09421904065321OviTex™ 1S Reinforced Tissue Matrix with Resorbable Polymer (OviTex 1S) is a sterile bioscaffo
09421904065314OviTex™ 1S Reinforced Tissue Matrix with Resorbable Polymer (OviTex 1S) is a sterile bioscaffo
09421904065307OviTex™ 1S Reinforced Tissue Matrix with Resorbable Polymer (OviTex 1S) is a sterile bioscaffo
09421904065291OviTex™ 1S Reinforced Tissue Matrix with Resorbable Polymer (OviTex 1S) is a sterile bioscaffo
09421904065284OviTex™ 1S Reinforced Tissue Matrix with Resorbable Polymer (OviTex 1S) is a sterile bioscaffo
09421904065277OviTex™ Core Reinforced Tissue Matrix with Resorbable Polymer (OviTex) is a sterile bioscaffol
09421904065260OviTex™ Core Reinforced Tissue Matrix with Resorbable Polymer (OviTex) is a sterile bioscaffol
09421904065253OviTex™ Core Reinforced Tissue Matrix with Resorbable Polymer (OviTex) is a sterile bioscaffol
09421904065246OviTex™ Core Reinforced Tissue Matrix with Resorbable Polymer (OviTex) is a sterile bioscaffol
09421904065239OviTex™ Core Reinforced Tissue Matrix with Resorbable Polymer (OviTex) is a sterile bioscaffol
09421904065222OviTex™ Core Reinforced Tissue Matrix with Resorbable Polymer (OviTex) is a sterile bioscaffol
09421904065215OviTex™ Core Reinforced Tissue Matrix with Resorbable Polymer (OviTex) is a sterile bioscaffol

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