OviTex LPR Reinforced Bioscaffold F10244-1525L

GUDID 09421906661552

OviTex™ Reinforced Tissue Matrix 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

Extra-gynaecological surgical mesh, biologic-polymer composite

Primary Device ID	09421906661552
NIH Device Record Key	74c443d0-9857-4110-88c2-62036f80a046
Commercial Distribution Status	In Commercial Distribution
Brand Name	OviTex LPR Reinforced Bioscaffold
Version Model Number	F10244-1525L
Catalog Number	F10244-1525L
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

Device Dimensions

Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Length	15 Centimeter
Width	25 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0

Operating and Storage Conditions

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	09421906661552 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K153632

FDA Product Code

FTM	Mesh, Surgical

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-06-23
Device Publish Date	2023-06-15

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09421906661569	OviTex™ Reinforced Tissue Matrix with Permanent Polymer (OviTex) is a sterile bioscaffold comp
09421906661552	OviTex™ Reinforced Tissue Matrix with Permanent Polymer (OviTex) is a sterile bioscaffold comp