OviTex Reinforced Bioscaffold With Resorbable Polymer (OviTex) F10256-2020G

GUDID 09421904065345

OviTex™ 1S Reinforced Tissue Matrix with Resorbable Polymer (OviTex 1S) is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and polyglycolic acid (PGA). The device consists of two sides: a textured and smooth side. The textured side of the device provides a surface conducive for tissue ingrowth. The smooth side of the device provides a surface designed to minimize tissue attachment. OviTex 1S will incorporate into the recipient tissue with associated cellular and microvascular ingrowth. OviTex 1S 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 ID	09421904065345
NIH Device Record Key	48dfba22-bbc9-454c-9981-b9a373877406
Commercial Distribution Status	In Commercial Distribution
Brand Name	OviTex Reinforced Bioscaffold With Resorbable Polymer (OviTex)
Version Model Number	F10256-2020G
Catalog Number	F10256-2020G
Company DUNS	594540572
Company Name	AROA BIOSURGERY LIMITED
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com
Phone	8448352246
Email	customerservice@telabio.com

Device Dimensions

Width	20 Centimeter
Length	20 Centimeter
Width	20 Centimeter
Length	20 Centimeter
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Length	20 Centimeter
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Width	20 Centimeter
Length	20 Centimeter
Width	20 Centimeter
Length	20 Centimeter
Width	20 Centimeter
Length	20 Centimeter
Width	20 Centimeter
Length	20 Centimeter
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Operating and Storage Conditions

Storage Environment Temperature	Between 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 25 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a dry environment.

Device Identifiers

Device Issuing Agency	Device ID
GS1	09421904065345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K153633

FDA Product Code

FTM	Mesh, Surgical

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2021-08-10
Device Publish Date	2016-09-24

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

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