OviTex Reinforced Bioscaffold With Permanent Polymer (OviTex) F10244-0610P

GUDID 09421904065017

OviTex™ Reinforced BioScaffold with Permanent Polymer (OviTex) is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and monofilament polypropylene colored with ([phathalocyaninato(2-)] copper). 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, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite
Primary Device ID09421904065017
NIH Device Record Key96ba2b25-9845-44f4-8afd-deed281625f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameOviTex Reinforced Bioscaffold With Permanent Polymer (OviTex)
Version Model NumberF10244-0610P
Catalog NumberF10244-0610P
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

Device Dimensions

Width10 Centimeter
Length6 Centimeter
Width10 Centimeter
Length6 Centimeter
Width10 Centimeter
Length6 Centimeter
Width10 Centimeter
Length6 Centimeter
Width10 Centimeter
Length6 Centimeter
Width10 Centimeter
Length6 Centimeter
Width10 Centimeter
Length6 Centimeter
Width10 Centimeter
Length6 Centimeter
Width10 Centimeter
Length6 Centimeter
Width10 Centimeter
Length6 Centimeter
Width10 Centimeter
Length6 Centimeter
Width10 Centimeter
Length6 Centimeter
Width10 Centimeter
Length6 Centimeter
Width10 Centimeter
Length6 Centimeter
Width10 Centimeter
Length6 Centimeter
Width10 Centimeter
Length6 Centimeter
Width10 Centimeter
Length6 Centimeter
Width10 Centimeter
Length6 Centimeter
Width10 Centimeter
Length6 Centimeter
Width10 Centimeter
Length6 Centimeter
Width10 Centimeter
Length6 Centimeter
Width10 Centimeter
Length6 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
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
GS109421904065017 [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 Number5
Public Version Date2020-10-21
Device Publish Date2016-09-24

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

09421904065758OviTex™ Reinforced BioScaffold with Permanent Polymer (OviTex) is a sterile bioscaffold compos
09421904065741OviTex™ Reinforced BioScaffold with Permanent Polymer (OviTex) is a sterile bioscaffold compos
09421904065734OviTex™ Reinforced BioScaffold with Permanent Polymer (OviTex) is a sterile bioscaffold compos
09421904065727OviTex™ Reinforced BioScaffold with Permanent Polymer (OviTex) is a sterile bioscaffold compos
09421904065710OviTex™ Reinforced BioScaffold with Permanent Polymer (OviTex) is a sterile bioscaffold compos
09421904065703OviTex™ Reinforced BioScaffold with Permanent Polymer (OviTex) is a sterile bioscaffold compos
09421904065208OviTex™ 2S Reinforced BioScaffold with Permanent Polymer (OviTex 2S) is a sterile bioscaffold
09421904065192OviTex™ 2S Reinforced BioScaffold with Permanent Polymer (OviTex 2S) is a sterile bioscaffold
09421904065185OviTex™ 2S Reinforced BioScaffold with Permanent Polymer (OviTex 2S) is a sterile bioscaffold
09421904065178OviTex™ 2S Reinforced BioScaffold with Permanent Polymer (OviTex 2S) is a sterile bioscaffold
09421904065161OviTex™ 2S Reinforced BioScaffold with Permanent Polymer (OviTex 2S) is a sterile bioscaffold
09421904065154OviTex™ 2S Reinforced BioScaffold with Permanent Polymer (OviTex 2S) is a sterile bioscaffold
09421904065147OviTex™ 2S Reinforced BioScaffold with Permanent Polymer (OviTex 2S) is a sterile bioscaffold
09421904065130OviTex™ 1S Reinforced BioScaffold with Permanent Polymer (OviTex 1S) is a sterile bioscaffold
09421904065123OviTex™ 1S Reinforced BioScaffold with Permanent Polymer (OviTex 1S) is a sterile bioscaffold
09421904065116OviTex™ 1S Reinforced BioScaffold with Permanent Polymer (OviTex 1S) is a sterile bioscaffold
09421904065109OviTex™ 1S Reinforced BioScaffold with Permanent Polymer (OviTex 1S) is a sterile bioscaffold
09421904065093OviTex™ 1S Reinforced BioScaffold with Permanent Polymer (OviTex 1S) is a sterile bioscaffold
09421904065086OviTex™ 1S Reinforced BioScaffold with Permanent Polymer (OviTex 1S) is a sterile bioscaffold
09421904065079OviTex™ 1S Reinforced BioScaffold with Permanent Polymer (OviTex 1S) is a sterile bioscaffold
09421904065062OviTex™ Reinforced BioScaffold with Permanent Polymer (OviTex) is a sterile bioscaffold compos
09421904065055OviTex™ Reinforced BioScaffold with Permanent Polymer (OviTex) is a sterile bioscaffold compos
09421904065048OviTex™ Reinforced BioScaffold with Permanent Polymer (OviTex) is a sterile bioscaffold compos
09421904065031OviTex™ Reinforced BioScaffold with Permanent Polymer (OviTex) is a sterile bioscaffold compos
09421904065024OviTex™ Reinforced BioScaffold with Permanent Polymer (OviTex) is a sterile bioscaffold compos
09421904065017OviTex™ Reinforced BioScaffold with Permanent Polymer (OviTex) is a sterile bioscaffold compos
09421904065000OviTex™ Reinforced BioScaffold with Permanent Polymer (OviTex) is a sterile bioscaffold compos

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