OviTex Reinforced Bioscaffold With Permanent Polymer (OviTex) F10244-2530P

GUDID 09421904065703

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 ID09421904065703
NIH Device Record Key147da26f-c9e5-4428-821d-6bb096b958e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameOviTex Reinforced Bioscaffold With Permanent Polymer (OviTex)
Version Model NumberF10244-2530P
Catalog NumberF10244-2530P
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

Length25 Centimeter
Width30 Centimeter
Length25 Centimeter
Width30 Centimeter
Length25 Centimeter
Width30 Centimeter
Length25 Centimeter
Width30 Centimeter
Length25 Centimeter
Width30 Centimeter
Length25 Centimeter
Width30 Centimeter
Length25 Centimeter
Width30 Centimeter
Length25 Centimeter
Width30 Centimeter
Length25 Centimeter
Width30 Centimeter
Length25 Centimeter
Width30 Centimeter
Length25 Centimeter
Width30 Centimeter
Length25 Centimeter
Width30 Centimeter
Length25 Centimeter
Width30 Centimeter
Length25 Centimeter
Width30 Centimeter
Length25 Centimeter
Width30 Centimeter
Length25 Centimeter
Width30 Centimeter
Length25 Centimeter
Width30 Centimeter
Length25 Centimeter
Width30 Centimeter
Length25 Centimeter
Width30 Centimeter
Length25 Centimeter
Width30 Centimeter
Length25 Centimeter
Width30 Centimeter
Length25 Centimeter
Width30 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
GS109421904065703 [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 Number2
Public Version Date2020-10-21
Device Publish Date2018-12-13

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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