OviTex Reinforced Bioscaffold With Permanent Polymer (OviTex)
Basic Information
- Brand Name
- OviTex Reinforced Bioscaffold With Permanent Polymer (OviTex)
- Primary DI
- 09421904065109
- Version / Model
- F10246-1020P
- Catalog Number
- F10246-1020P
- Company Name
- AROA BIOSURGERY LIMITED
- Labeler DUNS
- 594540572
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 8
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 3207bdfa-24f0-4c68-bd42-e0daaa25b76e
Device Description
OviTex™ 1S Reinforced Tissue Matrix with Permanent Polymer (OviTex 1S) is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and monofilament polypropylene colored with ([phathalocyaninato(2-)] copper). The device consists of two sides: a textured and smooth side. The textured side of the device, indicated with blue polypropylene, provides a surface conducive for tissue ingrowth. The smooth side of the device, containing clear polypropylene, 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | General, Plastic Surgery | 878.3300 | 2 |
| FTM | Mesh, Surgical | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09421904065109 | GS1 |
Customer Contacts
- Phone
- 8448352246
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153632 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 20 | Centimeter | |
| Length | 10 | Centimeter |