OviTex Reinforced Bioscaffold With Resorbable Polymer (OviTex)
Basic Information
- Brand Name
- OviTex Reinforced Bioscaffold With Resorbable Polymer (OviTex)
- Primary DI
- 09421904065314
- Version / Model
- F10256-1020G
- Catalog Number
- F10256-1020G
- 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
- 2023-10-04
- Public Version Status
- Update
- Public Device Record Key
- 850874f2-87d6-47b6-9623-2365315db232
Device Description
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.
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 |
|---|---|---|---|---|
| FTM | Mesh, Surgical | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60907 | Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial | A bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. 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 | 09421904065314 | GS1 |
Customer Contacts
- Phone
- 8448352246
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153633 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 20 | Centimeter | |
| Length | 10 | Centimeter |