AccessGUDID - DEVICE: OviTex LPR Reinforced Bioscaffold (09421904065802)

GUDID

Device Identifier (DI) Information

Brand Name: OviTex LPR Reinforced Bioscaffold
Version or Model: F10244-1523L
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: F10244-1523L
Company Name: AROA BIOSURGERY LIMITED

Primary DI Number: 09421904065802
Issuing Agency: GS1
Commercial Distribution End Date: December 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 594540572 *Terms of Use

Device Description: The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. OviTex Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device remodels and helps regenerate tissue while reinforcing the repair and providing structural support. Reinforced tissue matrices enhance performance while maintaining compatibility with the body. The OviTex Reinforced Tissue Matrix Device is used for hernia repair and abdominal wall reconstruction.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61545	Extra-gynaecological surgical mesh, biologic-polymer composite	A partially-bioabsorbable, implantable material (e.g., flat sheet) made from both a bioabsorbable animal-derived biologic (e.g., porcine collagen) and a non-bioabsorbable synthetic polymer (e.g., polypropylene) intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FTM	Mesh, Surgical
FTL	Mesh, Surgical, Polymeric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153632	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 18 Centimeter
Width: 23 Centimeter

Device Record Status

Public Device Record Key: 1c9b30c9-b45d-4a0a-8812-f7945646dc21
Public Version Date: December 02, 2024
Public Version Number: 7
DI Record Publish Date: October 26, 2018